FDA

FDA approves first drug in U.S. with digital ingestion tracking

FDA approves first drug in U.S. with digital ingestion tracking

Published 14/11/2017

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`s hepatitis B vaccine gets FDA nod on third try, shares up

Dynavax`s hepatitis B vaccine gets FDA nod on third try, shares up

Published 09/11/2017

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 Pharma gets tentative FDA approval for Lilly`s Alimta version

Eagle Pharma gets tentative FDA approval for Lilly`s Alimta version

Published 27/10/2017

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 units sue FDA over drug compounding policy

Endo International units sue FDA over drug compounding policy

Published 27/10/2017

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…]

GSK wins U.S. shingles vaccine approval, UK nod for gene therapy

GSK wins U.S. shingles vaccine approval, UK nod for gene therapy

Published 23/10/2017

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…]

FDA panel backs gene therapy for rare form of blindness

FDA panel backs gene therapy for rare form of blindness

Published 12/10/2017

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`s knee pain drug gets FDA nod, shares hit life high

Flexion`s knee pain drug gets FDA nod, shares hit life high

Published 06/10/2017

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…]

FDA aims to speed up arrival of complex generic drugs

FDA aims to speed up arrival of complex generic drugs

Published 02/10/2017

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…]

Eli Lilly wins U.S. approval for breast cancer drug

Eli Lilly wins U.S. approval for breast cancer drug

Published 28/09/2017

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 Duchenne drug may work, data inconclusive: FDA panel

PTC Therapeutics Duchenne drug may work, data inconclusive: FDA panel

Published 28/09/2017

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 Administration concluded on Thursday. [more…]