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FDA

Showing 15 posts of 1444 posts found.

Sun Pharma logo

FDA withdraws approval for Sun Pharma’s epilepsy drug

September 29, 2015
Manufacturing 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 …

News
Novo Nordisk building

FDA approves Novo Nordisk’s diabetes drugs

September 28, 2015
Sales 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 …

News
Amgen image

Amgen’s Kyprolis gets accelerated FDA review for expanded labelling

September 21, 2015
Sales 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 …

News

FDA grants Opdivo breakthrough status for kidney cancer

September 18, 2015
Research 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 …

News
GSK Worthing

GSK recalls 427,000 antibiotics after contamination scare

September 15, 2015
Manufacturing 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 …

News
fda_building

FDA strengthens safety warning for J&J’s diabetes drug Invokana

September 14, 2015
Sales 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 …

News
Proteus system

US FDA accepts first digital medicine application

September 11, 2015
Medical 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 …

News
scales

Standardising the pharma benefit-risk assessment process

September 1, 2015
Manufacturing 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 …

Feature
FDA sign

FDA issues gliptin joint pain warning

September 1, 2015
Manufacturing 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 …

News
boehringer_lilly

New Boehringer and Lilly type 2 diabetes treatment gets FDA nod

August 28, 2015
Research 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. …

News

FDA approves Amgen’s cholesterol lowering drug

August 28, 2015
Medical 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 …

News
Pharma pill manufacturing

FDA hits Mylan’s Indian plants with warning letter

August 20, 2015
Manufacturing 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 …

News
Sprout sign

FDA approves ‘female viagra’

August 19, 2015
Research 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’. …

News
fda2outsideweb

FDA approves limited OxyContin use in children

August 17, 2015
Sales 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 …

News

Abbvie and Roche report success in Phase II leukaemia trial

August 13, 2015
Research and Development AbbVie, Breakthrough Therapy Designation, CLL, EMA, FDA, Roche, chronic lymphocytic leukaemia, leukaemia, venetoclax

AbbVie plans to submit regulatory applications for its leukaemia drug venetoclax to the FDA and the EMA before the end …

News
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