FDA
FDA accepts Sandoz submission for Amgen biosimilar
October 2, 2015Medical Communications, Research and Development Amgen, FDA, Novartis, Sandoz, biosimilars
Sandoz, a Novartis company and a global leader in biosimilars, has announced today that the US Food and Drug Administration …
FDA withdraws approval for Sun Pharma’s epilepsy drug
September 29, 2015Manufacturing and Production Elepsia, FDA, Sun Pharma, epilepsy, levetiracetam, manufacturing, productions, seizures
Manufacturing problems at Sun Pharma’s production site has led the FDA to revoke the company’s approval for Elepsia XR for …
FDA approves Novo Nordisk’s diabetes drugs
September 28, 2015Sales and Marketing FDA, Novo Nordisk, Ryzodeg, Tresiba, diabetes, insulin
The FDA has approved two Novo Nordisk drugs, Tresiba and Ryzodeg, for the treatment of type 2 diabetes in adults.The …
Amgen’s Kyprolis gets accelerated FDA review for expanded labelling
September 21, 2015Sales and Marketing Amgen, FDA, Kyprolis, carfilzomib, multiple myeloma
The FDA has accepted for priority review Amgen’s supplemental new drug application for Kyprolis (carfilzomib) for patients with relapsed multiple …
FDA grants Opdivo breakthrough status for kidney cancer
September 18, 2015Research and Development, Sales and Marketing BMS, Breakthrough Therapy Designation, Bristol-Myers Squibb, FDA, Kidney cancer, immuno-oncology, immunotherapy, nivolumab, opdivo, renal cell carcinoma
The FDA has given Bristol-Myers Squibb’s immuno-oncology drug Opdivo Breakthrough Therapy Designation as a kidney cancer treatment. The FDA’s decision …
GSK recalls 427,000 antibiotics after contamination scare
September 15, 2015Manufacturing and Production Bactroban, FDA, GSK, manufacturing, product recalls, production, recalls
GlaxoSmithKline has had to recall more than 427,000 tubes of creams and ointments due to potential penicillin cross-contamination and the …
FDA strengthens safety warning for J&J’s diabetes drug Invokana
September 14, 2015Sales and Marketing FDA, Food and Drugs Administration, Invokamet, J&J, JJ, Johnson & Johnson, diabetes, invokana, safety warning, type 2 diabetes
Johnson & Johnson has suffered a blow after the FDA strengthened its safety warning for the company’s type 2 diabetes …
US FDA accepts first digital medicine application
September 11, 2015Medical Communications FDA, NDA, Otsuka, digital, digital medicine, proteus
The FDA has accepted the first New Drug Application for a digital medicine: Otsuka and Proteus Digital Health’s collaboration of …
Standardising the pharma benefit-risk assessment process
September 1, 2015Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, FDA, benefit-risk analysis, pharmacoepidemiology, pharmacovigilance
Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view …
FDA issues gliptin joint pain warning
September 1, 2015Manufacturing and Production DPP-4 inhibitors, ESC, FDA, TECOS, adverse effects, drug safety, gliptins, safety alert, safety warning
The FDA has issued a safety alert, warning of joint pain caused by the gliptins, a common class of drugs …
New Boehringer and Lilly type 2 diabetes treatment gets FDA nod
August 28, 2015Research and Development, Sales and Marketing Boehringer Ingelheim, Eli Lilly, FDA, Synjardy, type 2 diabetes
The FDA has approved Synjardy, from Boehringer Ingelheim and Eli Lilly, for the treatment of adults with type 2 diabetes. …
FDA approves Amgen’s cholesterol lowering drug
August 28, 2015Medical Communications, Research and Development Amgen, FDA, Repatha, evolocumab
The FDA has endorsed Amgen’s cholesterol-lowering medication, Repatha, for the use in patients with high cholesterol. It follows Amgen’s successful …
FDA hits Mylan’s Indian plants with warning letter
August 20, 2015Manufacturing and Production Contamination, FDA, Mylan, Pfizer, manufacturing, production
The FDA has served Mylan with a warning letter citing contamination at three of its manufacturing facilities in India. Inspections …
FDA approves ‘female viagra’
August 19, 2015Research and Development, Sales and Marketing Addyi, FDA, HSDD, Sprout, Sprout Pharmaceuticals, flibanserin, hypoactive sexual desire disorder
The FDA has approved Sprout Pharmaceuticals’ Addyi, a controversial libido-enhancing drug for women that has been dubbed the ‘female viagra’. …
FDA approves limited OxyContin use in children
August 17, 2015Sales and Marketing FDA, OxyContin, Purdue, Purdue Pharma, oxycodone
The FDA has approved the limited use of the strong painkiller Oxycontin for children in the US aged between 11 …
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