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Published March 11, 2011
Dendreon Corp. received approval from the FDA for the expansion of its NJ manufacturing facility, allowing the company to significantly increase the availability of Provenge. Read More »
Published March 10, 2011
Human Genome Sciences, Inc. and GlaxoSmithKline received approval from the FDA for Benlysta (belimumab) for the treatment of autoantibody-positive systemic lupus erythematosus (SLE) in patients receiving standard therapy. Read More »
Published March 10, 2011
Human Genome Sciences, Inc. and GlaxoSmithKline received approval from the FDA for Benlysta (belimumab) for the treatment of autoantibody-positive systemic lupus erythematosus (SLE) in patients receiving standard therapy. Read More »
Published March 8, 2011
Bristol-Myers Squibb and AstraZeneca’s NDA for dapagliflozin, an investigational drug for the treatment of type 2 diabetes, has been accepted by the FDA. Read More »
Published March 8, 2011
Bristol-Myers Squibb and AstraZeneca’s NDA for dapagliflozin, an investigational drug for the treatment of type 2 diabetes, has been accepted by the FDA. Read More »
Published March 3, 2011
Lyophilization Services of New England, Inc. (LSNE) has recently completed a comprehensive FDA audit of its medical device manufacturing facility in Manchester, NH. Read More »
By Stephen Barlas
Published February 15, 2011
Confusion, anxiety reign as Agency talks tagging Read More »
Published January 26, 2011
CMC issues halt HIV combo application Read More »
Published January 26, 2011
CMC issues halt HIV combo application Read More »
Published January 24, 2011
MuDelta to get accelerated review Read More »
Published January 24, 2011
MuDelta to get accelerated review Read More »
Published November 16, 2010
Halaven injection adds new option in metastatic breast cancer Read More »
Published November 16, 2010
Halaven injection adds new option in metastatic breast cancer Read More »
FDA Expectations for Parenteral Supplier Controls
By John Avellanet
Published November 10, 2010
Does a device guidance hold the key? Read More »
Published November 8, 2010
WuXi PharmaTech has been awarded a certificate of Good Laboratory Practice (GLP) compliance for its toxicology facility in Suzhou, from the State Food and Drug Administration (SFDA), China's regulatory authority. Read More »
Published October 20, 2010
Boehringer Ingelheim wins approval from the FDA for Pradaxa, the first new oral anticoagulant in the U.S. in more than 50 years. Read More »
Published October 20, 2010
Boehringer Ingelheim wins approval from the FDA for Pradaxa, the first new oral anticoagulant in the U.S. in more than 50 years. Read More »
Published October 15, 2010
Mylan Pharmaceuticals, Inc. received approval from the FDA for its ANDAs for the generic versions of antihypertensive drugs Hyzaar Tablets, 50 mg/12.5 mg and 100 mg/25 mg, and Cozaar Tablets, 25 mg, 50 mg and 100 mg. Read More »
Published October 15, 2010
Mylan Pharmaceuticals, Inc. received approval from the FDA for its ANDAs for the generic versions of antihypertensive drugs Hyzaar Tablets, 50 mg/12.5 mg and 100 mg/25 mg, and Cozaar Tablets, 25 mg, 50 mg and 100 mg. Read More »
Increased FDA Scrutiny of Purchasing / Supplier Controls
By Braulio Ortiz, Michael Neaves
Published October 8, 2010
Multiple perspectives on shifting regulatory burdens Read More »
Published September 22, 2010
Novel MS treatment reaches U.S. market Read More »
Published September 22, 2010
Novel MS treatment reaches U.S. market Read More »
Published August 19, 2010
CSL Behring received approval from the FDA for its sBLA to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Read More »
Published August 19, 2010
CSL Behring received approval from the FDA for its sBLA to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Read More »
Published July 26, 2010
Daiichi Sankyo received FDA approval of Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide), a new three-in-one combination drug taken once-daily for the treatment of hypertension in patients who are not adequately controlled with other anti Read More »
Published July 26, 2010
Daiichi Sankyo received FDA approval of Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide), a new three-in-one combination drug taken once-daily for the treatment of hypertension in patients who are not adequately controlled with other anti Read More »
Published June 25, 2010
Saltigo GmbH has passed an FDA audit at its Leverkusen site. Read More »
Published June 24, 2010
Merck received approval from the FDA for Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combo asthma treatment for patients 12 years of age and older. Read More »
Published June 24, 2010
Merck received approval from the FDA for Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combo asthma treatment for patients 12 years of age and older. Read More »
Published June 3, 2010
Perrigo Co. has received approval from the FDA for its aNDA for OTC Miconazole Nitrate Vaginal Cream and Suppository, a generic to Monistat -1 Combination Pack, for the treatment of vaginal yeast infections. Read More »
Published June 3, 2010
Perrigo Co. has received approval from the FDA for its aNDA for OTC Miconazole Nitrate Vaginal Cream and Suppository, a generic to Monistat -1 Combination Pack, for the treatment of vaginal yeast infections. Read More »
Published June 2, 2010
Amgen received approval from the FDA for Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Read More »
Published June 2, 2010
Amgen received approval from the FDA for Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Read More »
Published May 28, 2010
Celsis International has recently updated its Drug Master Files with the FDA to include information on testing both non-sterile and sterile raw materials, in-process solutions, and finished goods on the Celsis system. Read More »
Published May 26, 2010
Genzyme received marketing approval from the FDA for Lumizyme (alglucosidase alfa), produced at the 4000 L bioreactor scale at its manufacturing facility in Geel, Belgium. Read More »
Published May 26, 2010
Genzyme received marketing approval from the FDA for Lumizyme (alglucosidase alfa), produced at the 4000 L bioreactor scale at its manufacturing facility in Geel, Belgium. Read More »
Published May 25, 2010
The FDA has finalized the terms of the consent decree regarding Genzyme’s Allston manufacturing plant, subject to approval by the U.S. District Court for the District of Massachusetts. Read More »
Published May 7, 2010
Bayer HealthCare Pharmaceuticals received approval from the FDA for Natazia (estradiol valerate and estradiol valerate/dienogest) tablets for the prevention of pregnancy. Read More »
Published May 7, 2010
Bayer HealthCare Pharmaceuticals received approval from the FDA for Natazia (estradiol valerate and estradiol valerate/dienogest) tablets for the prevention of pregnancy. Read More »
Published May 3, 2010
AstraZeneca and Pozen, Inc. received approval from the FDA for Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of Read More »
Published May 3, 2010
AstraZeneca and Pozen, Inc. received approval from the FDA for Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of Read More »
Published April 30, 2010
Dendreon Corp. received approval from the FDA for Provenge (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). Read More »
Published April 30, 2010
Dendreon Corp. received approval from the FDA for Provenge (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). Read More »
Published April 22, 2010
Everolimus reaches U.S. market Read More »
Published April 22, 2010
Everolimus reaches U.S. market Read More »
Published April 14, 2010
Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) received approval from the FDA for its NDA for Pancreaze (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or ot Read More »
Published April 14, 2010
Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) received approval from the FDA for its NDA for Pancreaze (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or ot Read More »
Published April 7, 2010
The FDA has approved Purdue Pharma's NDA for a reformulation of OxyContin (oxycodone HCl controlled-release) Tablets. Read More »
Published April 7, 2010
The FDA has approved Purdue Pharma's NDA for a reformulation of OxyContin (oxycodone HCl controlled-release) Tablets. Read More »
Published March 25, 2010
The FDA has notified Genzyme Corp. that it intends to take enforcement action to ensure that products manufactured at the company’s Allston plant are made in compliance with GMP regulations. Read More »


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