FDA

Valeant says Bausch & Lomb’s over-the-counter eye drop gets FDA nod

Valeant says Bausch & Lomb’s over-the-counter eye drop gets FDA nod

Published 22/12/2017

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 [more…]

FDA approves La Jolla’s low blood pressure drug

FDA approves La Jolla’s low blood pressure drug

Published 21/12/2017

(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. [more…]

Aclaris’s drug to treat common skin growth gets FDA nod

Aclaris’s drug to treat common skin growth gets FDA nod

Published 15/12/2017

(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 [more…]

FDA allows Alnylam to restart hemophilia treatment trials

FDA allows Alnylam to restart hemophilia treatment trials

Published 15/12/2017

(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 [more…]

U.S. approves digital pill that tracks when patients take it

U.S. approves digital pill that tracks when patients take it

Published 14/11/2017

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 [more…]

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…]