(Reuters) – The U.S. Food and Drug Administration plans to release guidance on Tuesday outlining its conditions for approving a vaccine for the coronavirus, the Wall Street Journal reported, citing a summary of the guidance. The agency would require drugmakers... More »
(Reuters) – The U.S. Food and Drug Administration on Monday cleared a new version of Abbott Laboratories’ continuous glucose monitoring device, helping the company build upon the success of its fastest-growing diabetes product. FreeStyle Libre 2, which was app... More »
(Reuters) – An expert panel formed by the U.S. Food and Drug Administration has endorsed asbestos testing standards for cosmetics that reject long-held industry positions and reflect those of public health authorities and experts for thousands of plaintiffs wh... More »
(Reuters) – The U.S. Food and Drug Administration said on Wednesday it approved Merck & Co Inc’s Keytruda for a hard-to-treat form of bladder cancer, making it the first new treatment for the cancer in more than two decades. The therapy was approved for patien... More »
(Reuters) – Japan-based drugmaker Eisai Co’s U.S. subsidiary announced on Sunday that it had received approval from the U.S. Food and Drug Administration for its insomnia treatment in adult patients. The agency approved the drug, Dayvigo, in doses of 5 mg and ... More »
(Reuters) – GlaxoSmithKline’s HIV drugs division ViiV Healthcare said on Saturday that the U.S. Food and Drug Administration declined to approve its long acting HIV injection. ViiV, in which Pfizer and Shionogi have small stakes, said it received a so-called c... More »
(Reuters) – The U.S. Food and Drug Administration said on Friday it had approved Daiichi Sankyo Co Ltd and AstraZeneca Plc’s drug to treat an advanced form of breast cancer, three months ahead of schedule. AstraZeneca in March signed a licensing and collaborat... More »
(Reuters) – Shares of Sarepta Therapeutics Inc (SRPT.O) soared 31% on Friday after U.S. regulators shocked Wall Street by approving the company’s treatment for a muscle-wasting disorder less than four months after rejecting the drug over safety concerns. The F... More »
(Reuters) – Independent advisers to the U.S. Food and Drug Administration on Friday voted unanimously in favor of Horizon Therapeutics Plc’s experimental treatment for active thyroid eye disease, taking the drug closer towards potential approval. If approved, ... More »
(Reuters) – U.S. health regulators on Friday approved expanding the heart benefit claims Amarin Corp can make in promoting its drug Vascepa to include reducing the risk of heart attacks and strokes in high-risk patients, opening a multibillion-dollar market op... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Aquestive Therapeutics’ treatment for neurological disorder amyotrophic lateral sclerosis (ALS). Shares of the company, which developed riluzole oral film (ROF) and will market the film under... More »
(The Nov 16 story corrects to clarify in second graph that patients will be infused by a healthcare provider.) By John Miller and Carl O’Donnell (Reuters) – Novartis AG on Friday won U.S. approval for its experimental sickle cell disease drug, Adakveo, making ... More »
NEW YORK (Reuters) – The U.S. Food and Drug Administration on Friday downplayed the risk caused by contamination of the already recalled popular heartburn drug Zantac, and said its tests suggest it does not cause carcinogens to form after ingestion by patients... More »
(Reuters) – U.S. President Donald Trump plans to nominate Dr. Stephen Hahn, chief medical executive of the University of Texas MD Anderson Cancer Center, to lead the Food and Drug Administration, the White House said on Friday. If confirmed, Hahn, a radiation ... More »
(Reuters) – AstraZeneca’s diabetes drug Farxiga has been approved for use in the United States as a treatment to reduce the chances of hospitalisation for heart failure in adults with type-2 diabetes and other cardiovascular risks, the British drugmaker said o... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Alexion Pharmaceuticals Inc’s treatment for a second rare blood disorder, the company said. The treatment, Ultomiris, has already been approved in the United States, Japan and the European Un... More »
NEW YORK (Reuters) – The U.S. Food & Drug Administration said on Friday that it found that a sample from one lot of Johnson & Johnson’s baby powder contained chrysotile fibers, a type of asbestos, confirming test results the company disclosed earlier on Friday... More »
(Reuters) – U.S. and European drug regulators said on Friday they are reviewing the safety of the widely taken heartburn drug ranitidine, commonly known by the brand name Zantac, after they found traces of a probable cancer-causing impurity in some versions of... More »
(Reuters) – The U.S. Food and Drug Administration has approved Xeris Pharmaceuticals Inc’s glucagon therapy that aims to treat severely low sugar levels in diabetes patients, the drugmaker said on Tuesday. The condition, called hypoglycemia, can cause acute co... More »
(Reuters) – AbbVie Inc has priced its new rheumatoid arthritis treatment at $59,000 a year after gaining U.S. approval on Friday, a big boost for the drugmaker struggling with rising competition for Humira, its blockbuster therapy for the same condition. A fou... More »
(Reuters) – Roche Holding AG has priced its personalized cancer treatment, Rozlytrek, at about $17,050 per month, nearly half of the monthly price of a rival drug from Bayer AG and Eli Lilly and Co that was approved last year. Roche’s drug and Bayer/Lilly’s Vi... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Celgene Corp’s Inrebic to treat certain rare forms of bone marrow cancer called myelofibrosis, making it the second approved drug to treat the disease. Inrebic belongs to a class of drugs kno... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Daiichi Sankyo Co Ltd’s treatment for adult patients with a type of rare, non-cancerous tumor affecting joints and limbs. The label for the treatment, Turalio, includes a boxed warning flaggi... More »
(Reuters) – British drugmaker AstraZeneca Plc said on Monday the U.S. Food and Drug Administration declined to approve its diabetes treatment, Farxiga, for use as a supplement to insulin in adults with a rare-type of the condition. The company said the regulat... More »
(Reuters) – The U.S. drug regulator on Friday approved Palatin Technologies and Amag Pharmaceuticals’ drug to restore sexual desire in premenopausal women, the latest attempt to come up with a therapy that some have dubbed as “female Viagra”. The therapy, Vyle... More »
(Reuters) – The U.S. Food and Drug Administration and the Federal Trade Commission on Friday issued warning letters to four flavored e-liquid product makers, stepping up pressure on firms using social media influencers to promote their products. Social media m... More »
(Reuters) – The U.S. Food and Drug Administration declined to approve a drug developed by Sanofi SA and Lexicon Pharmaceuticals Inc intended for use with insulin in patients with type 1 diabetes, the companies said on Friday. The decision comes about two month... More »
(Reuters) – U.S. health regulators said on Friday a third cancer-causing toxin was found in some blood pressure pills recalled by India’s Hetero Labs Ltd a day earlier, adding to a global recall of commonly used drugs to treat hypertension. The U.S. Food and D... More »
(Reuters) – Endo International Plc said on Friday the U.S. health regulator has decided not to include blood pressure treatment vasopressin in its list of drugs that can be used in compounding, in a boost to the drugmaker that makes the only FDA-approved versi... More »
(Reuters) – The U.S. Food and Drug Administration said on Thursday it was taking action against certain retailers including Walgreen Boots Alliance for repeatedly flouting tobacco sale rules, including sale of cigars and menthol cigarettes to minors. Walgreens... More »
PARIS (Reuters) – The U.S. Food and Drug Administration approved Sanofi’s new pediatric vaccine immunizing children against six diseases, the French pharmaceutical lab said on Wednesday. Sanofi developed the new vaccine, dubbed Vaxelis, in partnership with Mer... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Stemline Therapeutics Inc’s Elzonris for the treatment of a rare blood disease in adults and children aged two years and above. This is the first approved treatment for the condition, blastic... More »
(Reuters) – The U.S. Food and Drug Administration approved on Friday Alexion Pharmaceuticals Inc’s rare blood disorder drug Ultomiris, an early backing that also solidifies the company’s dominant market position. The company’s flagship drug, Soliris, was the l... More »
(Reuters) – Insys Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its opioid painkiller, citing potential safety concerns. Insys shares slid nearly 9 percent to $6.62 on Friday, hitting their lowest level in more than ... More »
(Reuters) – U.S. Food and Drug Administration staff reviewers have raised doubts over the effectiveness of GlaxoSmithKline Plc’s drug Nucala in treating a disease that limits airflow to the lungs. Nucala, already approved for treating severe asthma patients, i... More »
(Reuters) – Agios Pharmaceuticals Inc said on Friday the U.S. Food and Drug Administration approved its treatment for a type of leukemia, the first targeted drug for patients with a specific genetic mutation. The company plans to launch the drug, Tibsovo, in t... More »
(Reuters) – The U.S. health regulator approved GW Pharmaceuticals Plc’s epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis. The... More »
CHICAGO (Reuters) – In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb wants to speed approval times for rivals to promising new first-to-market medicines. The U.S. Food and Drug Administration chi... More »
CHICAGO (Reuters) – The U.S. Food and Drug Administration is taking steps to streamline the approval process for cancer drugs, reviewing clinical trial data up front to make sure applications companies submit are complete. The new approach, outlined on Saturda... More »
(Reuters) – The U.S. Food and Drug Administration on Friday approved Novartis AG’s combination therapy to treat an aggressive type of thyroid cancer. The therapy, which uses Novartis’ Tafinlar and Mekinist, was approved to treat anaplastic thyroid cancer that ... More »
(Reuters) – Apricus Biosciences Inc said on Monday it was considering options for the company and looking to sell the U.S. rights to its erectile dysfunction cream Vitaros, after the Food and Drug Administration asked it to make a new formula for the product. ... More »
(Reuters) – The U.S. Food and Drug Administration (FDA) on Monday slapped restrictions on the sale of Bayer AG’s implanted birth control device Essure, two years after the agency put a severe warning label on the product. The FDA said here some women were not ... More »
(Reuters) – GlaxoSmithKline has won a further reprieve for its blockbuster Advair lung drug after U.S. regulators insisted Hikma Pharmaceuticals conduct a further clinical study evaluating its generic version of the drug. The Jordan-based firm said on Monday i... More »
(Reuters) – KemPharm Inc said on Friday the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the short-term management of acute pain, sending the shares of the drugmaker up as much as 36 percent in late afternoon trading. The company... More »
FILE PHOTO: A sign is seen at an AstraZeneca site in Macclesfield, central England May 19, 2014. REUTERS/Phil Noble/File Photo LONDON (Reuters) – AstraZeneca’s immunotherapy drug Imfinzi has won crucial approval from U.S. regulators for use in lung cancer, ope... More »
FILE PHOTO: – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo (Reuters) – The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences In... More »
FILE PHOTO: – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo (Reuters) – The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences In... More »
FILE PHOTO – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo (Reuters) – U.S. regulators have proposed lowering the bar for clinical trial success for experimental ... More »
(Reuters) – The U.S. Food and Drug Administration on Thursday approved a radioactive drug to treat the ultra-rare type of digestive tract cancer that killed Steve Jobs in 2011. The approval for Advanced Accelerator Applications SA’s Lutathera comes just days a... More »
A sign for the headquarters of Valeant Pharmaceuticals International Inc is seen in Laval, Quebec June 14, 2016. REUTERS/Christinne Muschi/File Photo (Reuters) – Canadian drugmaker Valeant Pharmaceuticals International Inc said the U.S. Food and Drug Administr... More »
(Reuters) – La Jolla Pharmaceutical said on Thursday the U.S. Food and Drug Administration had approved its drug, Giapreza, to treat dangerously low blood pressure. The company said it plans to make Giapreza available for patients in the United States in March... More »
(Reuters) – Aclaris Therapeutics Inc’s drug to treat a common kind of skin growth called seborrheic keratoses received approval from the U.S. Food and Drug Administration, the company said on Friday. It is the only topical medicine for the condition to receive... More »
(Reuters) – The U.S. Food and Drug Administration has allowed Alnylam Pharmaceuticals Inc to restart clinical trials on a drug to treat patients with a rare bleeding disorder, the company said on Friday. All ongoing studies of the drug, fitusiran, had been pla... More »
A digital pill with an embedded sensor to track if patients are taking their medication. REUTERS/Proteus Digital Health (Reuters) – U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication pr... More »
The U.S. Food and Drug Administration said on Monday that it had approved Otsuka Pharmaceutical Co Ltd's Abilify MyCite, the first drug with a digital ingestion tracking system to be approved in the United States. More »
Dynavax Technologies Corp's hepatitis B vaccine won the U.S. Food and Drug Administration's approval on the third attempt and Chief Executive Eddie Gray told Reuters the company was open to, but not waiting for, a partner to market the drug. More »
Eagle Pharmaceuticals Inc said on Friday the U.S. Food and Drug Administration tentatively approved its diluted version of Eli Lilly and Co's blockbuster cancer drug Alimta. More »
Endo International Plc said two units filed a lawsuit on Thursday accusing the U.S. Food and Drug Administration of ignoring key components of a law passed after a deadly 2012 meningitis outbreak linked to a compounding pharmacy. More »
GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three key products for which the British drugmaker expects approval this year. More »
Spark Therapeutics Inc's experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded on Thursday, paving the way for the first U.S. gene therapy for an inherited disease. More »
Flexion Therapeutics Inc said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration, sending the drug developer's shares soaring to a record high in regular trading on Friday. More »
The U.S. Food and Drug Administration on Monday announced a series of measures designed to speed to market generic versions of complex drugs such as Mylan NV's emergency EpiPen in an effort to address the rising cost of pharmaceuticals. More »
The U.S. Food and Drug Administration said on Thursday it approved an Eli Lilly and Co drug to treat advanced breast cancer that has progressed following prior treatment. More »
PTC Therapeutics Inc's experimental drug to treat Duchenne muscular dystrophy, a devastating degenerative disease that mostly affects young boys, may work but the company will need to do more work to prove it, an advisory panel to the U.S. Food and Drug Admini... More »
The head of the U.S. Food and Drug Administration said on Friday the agency is working on a new policy that would encourage more compounding pharmacies to register under a law enacted in the wake of a deadly 2012 meningitis outbreak linked to one such company. More »
The U.S. Food and Drug Administration said on Tuesday it has approved Medicines Co's antibacterial drug for patients with complicated urinary tract infections (cUTI). More »
Novo Nordisk said on Friday the U.S. Food and Drug Administration (FDA) approved an expanded use of its diabetes drug to reduce the risk of cardiovascular events such as heart attack and stroke. More »
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed The U.S. Food and Drug Administration on Friday approved a new oral blood-thinner made by Portola Pharmaceuticals Inc to preven... More »
FILE PHOTO – A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo The U.S. Food and Drug Administration on Monday approved Edwards Lifesciences Corp’s Sapien 3 artificia... More »
Senate Majority Leader Mitch McConnell (R-KY) speaks to Reuters during an interview in Washington, U.S., May 24, 2017. REUTERS/Joshua Roberts U.S. Senate Republican Leader Mitch McConnell told Reuters on Wednesday he expects bipartisan support for approval of ... More »
An Abbott company logo is pictured at the reception of its office in Mumbai, India, September 8, 2015. REUTERS/Shailesh Andrade The U.S. Food and Drug Administration issued a warning letter to Abbott Laboratories, citing manufacturing flaws with a range of car... More »
The U.S. Food and Drug Administration approved Neurocrine Biosciences Inc’s drug to treat tardive dyskinesia, a side effect of antipsychotic medications characterized by uncontrolled movements of the face and body, the company said. More »
Dr. Scott Gottlieb testifies before a Senate Health Education Labor and Pension Committee confirmation hearing on his nomination to be commissioner of the Food and Drug Administration on Capitol Hill in Washington, D.C., U.S. April 5, 2017. REUTERS/Aaron P. Be... More »
FILE PHOTO: A Marlboro cigarettes pack, a brand of Philip Morris Tobacco, lies next to an empty coffee cup at a cafe in central Sydney June 27, 2011. REUTERS/Daniel Munoz/File Photo Philip Morris International said on Friday it has applied for pre-market appro... More »
The GlaxoSmithKline building is pictured in Hounslow, west London June 18, 2013. REUTERS/Luke MacGregor/File Photo Mylan NV said on Wednesday the U.S. Food and Drug Administration declined to approve its generic version of GlaxoSmithKline Plc’s (GSK.L) blockbu... More »
Dr. Scott Gottlieb is seen in this American Enterprise Institute photo released in Washington, DC, U.S., March 10, 2017. Courtesy The American Enterprise Institute/Handout via REUTERS Dr. Scott Gottlieb, President Donald Trump’s nominee to lead the U.S. Food a... More »
U.S. health regulators on Thursday approved a drug developed by Merck KGaA and Pfizer Inc that helps the immune system to fight a rare form of skin cancer once it has spread to other parts of the body. More »
Merck & Co Inc said on Tuesday it had got a nod from the U.S. Food and Drug Administration for its already-approved immunotherapy drug Keytruda as a treatment for a type of blood cancer. More »
The benefits of Endo International Plc’s long-acting opioid painkiller no longer outweigh its risks, an independent panel to the U.S. Food and Drug Administration (FDA) concluded on Tuesday. More »
Dr. Scott Gottlieb is seen in this American Enterprise Institute photo released in Washington, DC, U.S., March 10, 2017. Courtesy The American Enterprise Institute/Handout via REUTERS U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative he... More »
The U.S. Food and Drug Administration said on Tuesday it had approved Lexicon Pharmaceuticals Inc’s oral drug to treat carcinoid syndrome diarrhea, a condition that develops in patients with gastrointestinal tumors. More »
FILE PHOTO – The Pfizer logo is seen at their world headquarters in Manhattan, New York, U.S., August 1, 2016. REUTERS/Andrew Kelly/File Photo The U.S. Food and Drug Administration said Pfizer Inc’s process for manufacturing sterile injectable drugs at a plant... More »
The U.S. Food and Drug Administration on Monday approved Egalet Corp’s long-acting opioid painkiller, Arymo ER, and will allow the company to claim it deters abuse by those seeking to dissolve and inject it. More »
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed U.S regulators said on Friday they would allow Eli Lilly and Co to state that its diabetes drug Jardiance reduces risk of death... More »
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo Dynavax Technologies Corp said on Monday the U.S. Food and Drug Administration had rejected the marketing applicatio... More »
The U.S. Food and Drug Administration on Friday banned some over-the-counter antibacterial hand and body wash products, saying they are no more effective than soap and water and could cause long-term harm. More »
CHICAGO A new type of cancer drug that takes the brakes off the body’s immune system has given drugmakers some remarkable wins against the deadly disease, but a top U.S. regulator says too many companies are focused on the same approach. Dr. Richard Pazdur, he... More »
U.S. Food and Drug Administration staff released voting questions on Teva Pharmaceutical Industries Ltd’s long-acting opioid painkiller for a panel of independent experts who will recommend to the agency whether to approve the drug. An FDA spokesman on Friday ... More »
An experimental, long-acting painkiller made by Teva Pharmaceutical Industries Ltd does not have abuse-resistant properties when taken orally, according to a preliminary review by the U.S. Food and Drug Administration. The drug, whose proposed trade name is Va... More »
Novartis AG said on Friday it received the U.S. Food and Drug Administration’s regular approval for a drug combination to treat an aggressive form of skin cancer. The FDA approved Tafinlar and Mekinist for treatment of metastatic melanoma based on two years ov... More »
CHICAGO U.S. health regulators on Thursday cleared the way for a type of genetically engineered Atlantic salmon to be farmed for human consumption – the first such approval for an animal whose DNA has been scientifically modified. Five years ago, the U.S. Food... More »
The U.S. Food and Drug Administration said on Friday it approved Baxalta Inc’s drug for use in patients with a type of rare bleeding disorder. The drug, Adynovate, was approved to control and reduce the frequency of bleeding episodes in patients with Hemophili... More »
Merck & Co’s drug to reverse the effects of muscle relaxants used in surgery is safe and effective enough to warrant approval, an independent panel to the U.S. Food and Drug Administration said. The drug, which goes by the chemical name of sugammadex, has repe... More »
The U.S. Food and Drug Administration said it approved Johnson & Johnson’s chemotherapy to treat specific soft-tissue sarcomas (STS) that have spread to other parts of the body or cannot be removed by surgery. The drug, Yondelis, is designed to delay the progr... More »
An independent panel of advisers to the U.S. Food and Drug Administration on Friday voted 10-4 in favor of approving AstraZeneca Plc’s gout drug. All 10 who backed the drug, lesinurad, qualified their vote by urging the FDA to ask AstraZeneca for studies after... More »
The U.S. Food and Drug Administration on Friday approved Merck & Co Inc’s immunotherapy, Keytruda, for patients with the most common form of lung cancer whose tumors produce a specific biological marker. The FDA approval for Keytruda in advanced non-small cell... More »
