FDA
Sanofi and Regeneron score FDA approval for arthritis
May 23, 2017Manufacturing and Production, Sales and Marketing FDA, Kevzara, arthritis, sarilumab
The FDA has awarded Sanofi and Regeneron’s Kevzara (sarilumab) approval for the treatment of moderate to severely active rheumatoid arthritis …
Dr Reddy’s gets greenlight to market Doxil generic
May 18, 2017Sales and Marketing Dr Reddy's, FDA
Dr Reddy’s Laboratories, one of India’s largest pharmaceutical firms, has revealed that the FDA has given the go-ahead to market …
Bayer celebrates FDA priority review for investigational blood cancer drug
May 17, 2017Research and Development, Sales and Marketing Bayer, FDA, blood cancer
Bayer has announced that its investigational blood cancer treatment copanlisib has been awarded priority review designation from the FDA, meaning …
Sangamo secures FDA’s Fast Track Designation for haemophilia candidate
May 17, 2017Research and Development, Sales and Marketing FDA, Pfizer, Sangamo Therapeutics
Sangamo Therapeutics has announced that the FDA has granted its cDNA gene therapy candidate for haemophilia A Fast Track Designation. …
New FDA Commissioner Gottlieb restructures workforce with product-based focus areas
May 16, 2017Manufacturing and Production, Sales and Marketing FDA, Scott Gottlieb
Scott Gottlieb has wasted no time since his appointment to the role of FDA Commissioner last week. As one of …
FDA green-lights Alembic’s cholesterol drug
May 15, 2017Sales and Marketing Alembic, FDA, cholesterol
Alembic Pharmaceuticals has announced that its fenofibric acid delayed-release capsules have been approved by the FDA for reducing high cholesterol …
Scott Gottlieb appointed to the FDA’s top role
May 11, 2017Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Scott Gottlieb, appointment
After months of scrutiny, Scott Gottlieb has been confirmed as the new Commissioner of the FDA, following his nomination by …
Scott Gottlieb appointed to the FDA’s top role
May 10, 2017Manufacturing and Production, Research and Development, Sales and Marketing FDA, Scott Gottlieb, Trump
After months of scrutiny, Scott Gottlieb has been confirmed as the new Commissioner of the FDA, following his nomination by …
Scott Gottlieb enters final stage of approval for FDA Commissioner role
April 28, 2017Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Trump, scotrt gottlieb
Trump’s pick for the top job in the FDA moved one step closer to taking up the job when the …
FDA condemns 14 companies selling fraudulent cancer ‘cures’ online
April 26, 2017Research and Development, Sales and Marketing Cancer, FDA
The FDA has struck out against a wave of companies offering cancer treatments online which fraudulently claim to be able …
FDA restricts administration of strong pain killers to children
April 21, 2017Medical Communications, Sales and Marketing FDA, opioid
The FDA has announced that it will require medication including codeine and tramadol, two high-strength painkillers, to have its strongest …
FDA warns of dangers of Hyland’s homeopathic teething tablets as recall is issued
April 18, 2017Manufacturing and Production, Sales and Marketing FDA, Hyland, recall
After months of FDA warnings, Hyland has finally issued an official voluntary recall of its homeopathic teething tablets, with the …
FDA warning slams St Jude’s “inadequate response” to device failures
April 13, 2017Medical Communications, Sales and Marketing FDA, st jude medical
St Jude Medical has been hit with a warning letter from the FDA over the medical device manufacturer’s failure to …
FDA approves first and only tardive dyskinesia treatment
April 12, 2017Research and Development, Sales and Marketing FDA, Neurocrine Biosciences, tardive dyskinesia
US patients suffering with tardive dyskinesia (TD) will see access to the first approved treatment in the country with the …
FDA approves first two antiviral hep C drugs for paediatric patients
April 10, 2017Sales and Marketing FDA, harvoni, hepatitis C, sovaldi
The FDA has given the go-ahead for two hepatitis C treatments for use in young and adolescent patients: Sovaldi (sofosbuvir) …
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