FDA panel backs Gilead’s Truvada to prevent HIV

FDA rejects 2 HIV drugs from Gilead Sciences

FOSTER CITY, Calif.—Gilead Sciences Inc. said Monday that the Food and Drug Administration rejected two marketing applications for HIV treatments, citing quality control problems at the company's manufacturing facilities.

denverpost.com (19 days ago)

FDA rejects two Gilead HIV drugs as standalone products

WASHINGTON (Reuters) - Gilead Sciences Inc said on Monday that U.S. health rejected two of its HIV drugs as standalone therapies, citing deficiencies in documentation and validation of certain quality testing procedures.

reuters.com (19 days ago)

Gilead fails FDA approval for two HIV drugs in 4-in-1 pill Stribild

The Food and Drug Administration cited 'deficiencies in documentation and validation of certain quality testing procedures and methods,' Foster City-based Gilead said in a statement today. The company said it's working with the FDA to address the agency's questions.

mercurynews.com (19 days ago)

FDA rejects two HIV drugs as stand-alone treatments

Pills elvitegravir and cobicistat are part of four-in-one treatment called Stribild; Gilead had asked FDA to approve two drugs as stand-alone treatments

cbsnews.com (19 days ago)

Gilead Misses Analysts' Profit Estimates on Sales of HIV Drugs

Gilead Sciences, the world's biggest maker of AIDS medicines, reported first-quarter profit that missed analysts' estimates on declining sales of its HIV drugs.

mercurynews.com (16 days ago)

Don't Worry for a Second About Gilead's Earnings Miss

Filed under: Investing Gilead Sciences shares have steadily risen more than 90% over the past year. The biotech announced first-quarter results after the market closed on Thursday, though, that weren't all that impressive. Will this be a problem for Gilead? I doubt it. By the numbersFirst quarter non-GAAP earnings came in at $801.9 million, or $0.48 per diluted share....

dailyfinance.com (15 days ago)

The FDA Issues a Stunning Rejection

Filed under: Investing In this video, health-care analyst David Williamson discusses the FDA's shocking rejection of two drugs they already approved. Gilead Sciences received a complete response letter for HIV drugs elvitegravir and cobicistat, both of which are currently components of the big biotech's quad pill Stribild. Watch and find out why the FDA came to this...

dailyfinance.com (19 days ago)

Gilead, Teva reach settlement in Viread patent lawsuit

(Reuters) - Gilead Sciences Inc said it has agreed with Israel's Teva Pharmaceuticals Industries Ltd to settle a lawsuit relating to patents protecting Viread, a treatment for HIV infection and chronic hepatitis B.

reuters.com (2 months and 28 days ago)

FDA Panel Backs Brain Stimulator for Epilepsy

msn.com (2 months and 24 days ago)

Aveo, Delcath FDA Panel Live Blog

Aveo, Delcath FDA Panel Live Blog BOSTON (TheStreet) -- Welcome to the doubleheader FDA advisory panel live blog: The morning panel features Aveo Oncology and its kidney cancer drug tivozanib. In the afternoon session, Delcath Systems brings the Melblez liver-tumor therapy in front of the FDA's outside experts. The panel experts will consider the efficacy and safety of...

thestreet.com (16 days ago)