FDA
Pfizer’s Lyrica achieves endpoint as adjunct in paediatric epilepsy
May 18, 2018Medical Communications, Research and Development FDA, Lyrica, Pfizer, epilepsy, pharma
Pfizer has revealed new Phase 3 data for its oral epilepsy therapy Lyrica (pregbalin) as an adjunctive treatment for partial …
FDA green lights first non-opioid therapy to manage symptoms of opioid withdrawal
May 17, 2018Sales 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 …
FDA issues warning letter over potential for poisoning at India plant
May 15, 2018Manufacturing 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 …
FDA awards first paediatric MS approval to Novartis’ Gilenya
May 14, 2018Sales 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) …
FDA launches lawsuits against stem cell clinics after patients rendered blind
May 10, 2018Medical 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 …
FDA approves Novartis combo in rare thyroid cancer subtype
May 8, 2018Manufacturing 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, 2018Manufacturing 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 …
Top Ten most popular articles on Pharmafile.com this week
April 27, 2018Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Eli Lilly, FDA, Fresenius, Shire, Takeda, arthritis, pharma
The year seems like it’s running away as we come to the end of April. It’s been a more tense …
Two FDA drug review Directors to leave the agency, with no permanent replacements in place
April 27, 2018Medical 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 …
FDA moots a return look at Acadia’s lead drug
April 27, 2018Medical 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, 2018Medical 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, 2018Research 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 …
All indications point to approval for cannabis-based therapy
April 17, 2018Research 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, 2018Manufacturing 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 …
Alkermes sent reeling as FDA refuses review of depression treatment
April 3, 2018Manufacturing 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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Five Facts about cardiovascular disease
