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FDA

Showing 15 posts of 1442 posts found.

Sangamo secures FDA’s Fast Track Designation for haemophilia candidate

May 17, 2017
Research 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. …

News

New FDA Commissioner Gottlieb restructures workforce with product-based focus areas

May 16, 2017
Manufacturing 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 …

News
fdaoutsideweb

FDA green-lights Alembic’s cholesterol drug

May 15, 2017
Sales 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 …

News
scott_gottlieb

Scott Gottlieb appointed to the FDA’s top role

May 11, 2017
Business 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 …

Appointment
scott_gottlieb

Scott Gottlieb appointed to the FDA’s top role

May 10, 2017
Manufacturing 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 …

News
scott_gottlieb

Scott Gottlieb enters final stage of approval for FDA Commissioner role

April 28, 2017
Manufacturing 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 …

News

FDA condemns 14 companies selling fraudulent cancer ‘cures’ online

April 26, 2017
Research 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 …

News
cough_syrup

FDA restricts administration of strong pain killers to children

April 21, 2017
Medical 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 …

News

FDA warns of dangers of Hyland’s homeopathic teething tablets as recall is issued

April 18, 2017
Manufacturing 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 …

News
fdaoutsideweb

FDA warning slams St Jude’s “inadequate response” to device failures

April 13, 2017
Medical 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 …

News
fdaoutsideweb

FDA approves first and only tardive dyskinesia treatment

April 12, 2017
Research 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 …

News
gilead-sciences

FDA approves first two antiviral hep C drugs for paediatric patients

April 10, 2017
Sales 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) …

News
gsk_wall

GSK hit by recall of 600,000 inhalers

April 5, 2017
Manufacturing and Production, Research and Development FDA, GSK, Ventolin

The FDA has released that GSK would be voluntarily recalling close to 600,000 of its Ventolin asthma inhalers across the …

News
teva_copy

Teva’s Huntington’s treatment becomes first FDA-approved deuterated drug

April 4, 2017
Manufacturing and Production, Sales and Marketing Austedo, FDA, Teva

Israel’s Teva Pharmaceuticals has announced that the FDA has given its approval for Austedo (deutetrabenazine) in the treatment of chorea …

News
1280px-epi-pen_1

FDA issues US-wide recall of Mylan’s EpiPen

April 3, 2017
Medical Communications, Sales and Marketing FDA, Mylan, epipen

After recent reports of around 80,000 defective EpiPen’s across Australia, New Zealand, Japan, Norway, Denmark, Finland and Ireland, the FDA …

News
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