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RSS FeedPosted by Michael Wonder on 26 Jul 2016
Daratumumab receives breakthrough therapy designation from U.S. Food and Drug Administration in combination with standard of care regimens for previously treated multiple myeloma
26 July 2016 - Marks second breakthrough therapy designation for daratumumab. ...
Posted by Michael Wonder on 25 Jul 2016
AbbVie receives U.S. FDA approval of once daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of genotype 1 chronic hepatitis C
25 July 2016 - New extended-release formulation is the first all-oral, co-formulated treatment containing the three direct-acting antiviral components of Viekira ...
Posted by Michael Wonder on 25 Jul 2016
Ocular Therapeutix receives complete response letter from FDA for its NDA for Dextenza for the treatment of post-surgical ocular pain
25 July 2016 - Outstanding items pertain to manufacturing process and controls. ...
Posted by Michael Wonder on 24 Jul 2016
Generic Crestor wins approval, dealing a blow to AstraZeneca
20 July 2016 - The FDA said Wednesday that it had approved generic versions of the blockbuster cholesterol-lowering pill Crestor, rejecting ...
Posted by Michael Wonder on 22 Jul 2016
Spark Therapeutics and Pfizer announce receipt of FDA breakthrough therapy designation for SPK-9001 for the treatment of hemophilia B
21 July 2016 - Spark Therapeutics and Pfizer announced today that the U.S. FDA has granted breakthrough therapy designation to SPK-9001, ...
Posted by Michael Wonder on 22 Jul 2016
Valeant Pharmaceuticals receives complete response letter from the FDA
22 July 2016 - FDA letter related to current good manufacturing practice at Bausch & Lomb facility. ...
Posted by Michael Wonder on 22 Jul 2016
Merck provides regulatory update on biologics licensing application for investigational agent bezlotoxumab
22 July 2016 - Merck today said that the U.S. FDA has requested the submission of new data and analyses from ...
Posted by Michael Wonder on 20 Jul 2016
Cerulean receives FDA fast track designation for CRLX101 for the treatment of platinum-resistant ovarian cancer
19 July 2016 - Cerulean Pharma today announced that the U.S. FDA granted fast track designation for Cerulean's lead nanoparticle-drug conjugate, ...
Posted by Michael Wonder on 20 Jul 2016
U.S. FDA approves Belviq XR, a once-daily formulation of lorcaserin for chronic weight management
19 July 2016 - Eisai Co., Ltd. announced today that the U.S. FDA has approved a new drug application for Belviq ...
Posted by Michael Wonder on 20 Jul 2016
Valeant and Progenics announce FDA approves Relistor tablets for the treatment of opioid-induced constipation in adults with chronic non-cancer pain
19 July 2016 - Valeant Pharmaceuticals and Progenics Pharmaceuticals, Inc. today announced that the U.S. FDA has approved Relistor (methylnaltrexone bromide) ...
Posted by Michael Wonder on 20 Jul 2016
Bristol-Myers Squibb announces availability of FDA approved Orencia (abatacept) ClickJect, a self-administered subcutaneous autoinjector, for adults with moderate to severe rheumatoid arthritis
20 July 2016 - Bristol-Myers Squibb announced today the commercial launch of the Orencia ClickJect Autoinjector, a new self-administered autoinjector for ...
Posted by Michael Wonder on 19 Jul 2016
FDA knocks back Novartis copy of Amgen's drug Neulasta
19 July 2016 - U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections ...
Posted by Michael Wonder on 19 Jul 2016
U.S. FDA expands indication for type 2 diabetes treatment Synjardy (empagliflozin/metformin hydrochloride) to include treatment-naïve adults
19 July 2016 - The U.S. FDA has approved an expanded indication for Synjardy (empagliflozin and metformin hydrochloride) tablets to include ...
Posted by Michael Wonder on 19 Jul 2016
U.S. FDA approves Prezista (darunavir) for use in pregnant women with HIV
18 July 2016 - Data show Prezista is a safe and effective treatment option in pregnant women, with no reports of ...
Posted by Michael Wonder on 18 Jul 2016
Generic drug approvals since the 1984 Hatch-Waxman Act
18 July 2016 - This study uses US FDA data to identify approved generic drugs manufactured between September 30, 1984, and ...