GAO report hammers FDA for lax oversight on speedily approved drugs

Carly Helfand These days, the FDA is approving more and more drugs under its expedited programs, meaning new treatments are getting to patients faster. The problem? The agency ...

FibroGen’s anemia drug, not yet approved, is a hit among cheating cyclists

Damian Garde FibroGen's in-development treatment for anemia is still in the midst of Phase III development, but thanks to a legal loophole, the pill has made its way into the world ...

Actavis snaps up Durata, newly approved antibiotic in $675M buyout

John Carroll Buyout-hungry Actavis–which is alternatively spotlighted as both a buyer and a possible buyout target–has snapped up Chicago-based Durata Therapeutics and its ...

UPDATE: Ranbaxy’s generic of Novartis blockbuster Diovan approved for launch

Eric Palmer The long-delayed and highly anticipated launch of generic Diovan is on the way, which is a bummer for Novartis and a huge boost for Indian drugmaker Ranbaxy Laboratories. ...

Once-Daily Dual Bronchodilator Ultibro Inhalation Capsules Approved for the Treatment of COPD in Japan

barbara.lempert Sosei Group Corporation: First in Class Once-Daily Dual Bronchodilator Ultibro Inhalation Capsules (QVA149) Approved for the Treatment of COPD in Japan     Once-daily ...

Orexo: Abstral Approved in Japan

barbara.lempert September 20, 2013 03:33 AM Eastern Daylight Time UPPSALA, Sweden–(BUSINESS WIRE)–Regulatory News: Orexo AB (STO:ORX) today announced the approval of ...

Celgene’s Abraxane approved for first-line treatment of pancreatic cancer

Eric Palmer The FDA today approved Celgene's Abraxane for pancreatic cancer, an approval that provides some hope for extending the lives of patients with the aggressive cancer. ...

J&J’s Simponi Aria approved for RA as it heads for blockbuster stratosphere

Eric Palmer The FDA has approved Simponi in combination with methotrexate to treat moderately to severely active rheumatoid arthritis. The company points out that an ...

Given Imaging’s PillCam Colon approved in Japan

barbara.lempert TEL AVIV,  July 15 (GLOBES)–Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) today announced that Japan’s Pharmaceuticals & Medical Devices Agency (PMDA) ...

Breo Ellipta Approved for COPD Treatment in Canada

barbara.lempert MISSISSAUGA, ON, July 10, 2013 /CNW/ – BREO™ ELLIPTA™ (fluticasone furoate/vilanterol) has been approved in Canada for the long-term once-daily maintenance ...

Novavax and Isconova to Combine; Novavax’ Swedish Prospectus Approved

barbara.lempert ROCKVILLE, Md., July 8, 2013 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq:NVAX) announced today the approval in Sweden of its prospectus related to its recommended ...

Prograf Approved for New Indication in Japan

barbara.lempert Approval of Prograf® capsules in Japan for the additional indication of interstitial pneumonia associated with polymyositis /dermatomyositis June 14, 2013 TOKYO, ...
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