FDA

Showing 15 posts of 1444 posts found.

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FDA green lights first non-opioid therapy to manage symptoms of opioid withdrawal

May 17, 2018
Sales and Marketing FDA, Lucemyra, opioid crisis, opioids, pharma

As the opioid epidemic continues to grip the US as the leading cause of deaths in those under the age …

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FDA issues warning letter over potential for poisoning at India plant

May 15, 2018
Manufacturing and Production FDA, India, biotech, drugs, pharma, pharmaceutical

The FDA has noted a number of failings at a plant in Gujarat, India, but mostly significantly was the finding …

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FDA awards first paediatric MS approval to Novartis’ Gilenya

May 14, 2018
Sales and Marketing FDA, gilenya, multiple sclerosis, pharma

The FDA has awarded approval for what it says is its first drug for the treatment of multiple sclerosis (MS) …

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FDA launches lawsuits against stem cell clinics after patients rendered blind

May 10, 2018
Medical Communications, Sales and Marketing FDA, Stem cells, US, macular degeneration, pharma

At the request of the FDA, The US Department of Justice has launched legal action seeking to shut down stem …

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FDA approves Novartis combo in rare thyroid cancer subtype

May 8, 2018
Manufacturing and Production, Sales and Marketing Cancer, FDA, Tafinlar, mekinist, thyroid cancer

The FDA has announced its decision to approve the use of Novartis’ combination of Tafinlar (dabrafenib) and Mekinist (trametinib) in …

Genmab and Janssen’s Darzalex combo scores FDA approval in multiple myeloma

May 8, 2018
Manufacturing and Production, Sales and Marketing FDA, Genmab, Janssen, US, darzalex, multiple myeloma, pharma

Genmab and Janssen have revealed that their combination of Darzalex (daratumumab) with bortezomib (Velcade), melphalan, and prednisone (VMP) has received …

Two FDA drug review Directors to leave the agency, with no permanent replacements in place

April 27, 2018
Medical Communications, Sales and Marketing FDA, pharma

The FDA has revealed that two of its prominent Directors are set to retire from the agency, leaving three of …

fda2outsideweb

FDA moots a return look at Acadia’s lead drug

April 27, 2018
Medical Communications, Sales and Marketing Acacia, FDA, nuplazid, pharma

Following a non-profit report that higher rates of death were associated with Acadia Pharmaceuticals’ Nuplazid, Scott Gottlieb has made comments …

Lilly and Incyte’s resubmission of arthritis drug data fails to assuage FDA concerns

April 20, 2018
Medical Communications, Sales and Marketing Eli Lilly, FDA, Incyte, baricitinib, pharma, rheumatoid arthritis

Eli Lilly and Incyte are facing more complications in the US approval of their experimental rheumatoid arthritis (RA) drug baricitinib …

BMS’ Opdivo+Yervoy combo secures FDA approval in kidney cancer

April 18, 2018
Research and Development, Sales and Marketing BMS, Bristol Myers Swuibb, Cancer, FDA, Yervoy, carcinoma, opdivo, pharma

The FDA has announced its approval of a combination of Opdivo (nivolumab) and Yervoy (ipilimumab), both products from Bristol Myers …

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All indications point to approval for cannabis-based therapy

April 17, 2018
Research and Development, Sales and Marketing FDA, GW Pharma, biotech, drugs, pharma, pharmaceutical

GW Pharma are inching step by step towards a likely approval with the FDA, after it received a strong recommendation …

FDA flip-flops on Alkermes’ drug application

April 17, 2018
Manufacturing and Production, Sales and Marketing Alkermes, FDA, biotech, drugs, pharma, pharmaceutical

Two weeks ago, it looked like the hopes for Alkermes’ ALKS 5461 receiving approval would rely on returning to the …

fda2outsideweb

Alkermes sent reeling as FDA refuses review of depression treatment

April 3, 2018
Manufacturing and Production, Research and Development, Sales and Marketing Alkermes, FDA, depression, major depressive disorder, pharma

Alkermes shares were knocked down to their lowest level since October 2016 after it was revealed that the FDA had …

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US “right to try” legislation passes after initial defeat

March 22, 2018
Medical Communications, Research and Development, Sales and Marketing FDA, House of representatives, Right to try, US, pharma

The controversial and much-discussed “right to try” bill has been passed in the US House of Representatives, quickly rebounding after …

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