FDA

Showing 15 posts of 1442 posts found.

jazz_pharma

FDA authorises Jazz Pharma’s sleep disorder therapy Sunosi

March 22, 2019
Medical Communications, Sales and Marketing FDA, jazz pharmaceuticals, pharma, sleep apnoea

Jazz Pharmaceuticals has announced that its dopamine and norepinephrine reuptake inhibitor (DNRI) Sunosi (solriamfetol) has been approved by the FDA …

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Top Ten most popular articles on Pharmafile.com this week!

March 22, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AstraZeneca, Biogen, Eisai, FDA, Merck, NICE, Pfizer, Roche, Sandoz

This week was a bad week for clinical trials. While the FDA put Roche and AbbVie’s multiple myeloma trial on …

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Specialists petition FDA over opioid approval process

March 22, 2019
Medical Communications FDA, approval process, opioid crisis, opioids, painkillers

FDA officials have called on the federal agency to halt the approval of new narcotic painkillers. Dr Sidney Wolfe, a …

Roche’s Tecentriq chalks up another FDA approval, this time in first-line extensive-stage small cell lung cancer

March 20, 2019
Research and Development, Sales and Marketing FDA, Roche, lung cancer, pharma, tecentriq

Roche has secured another US approval for its immunotherapy Tecentriq (atezolizumab), as the FDA reveals its approval of the drug …

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FDA puts multiple myeloma trial on hold after patient deaths

March 20, 2019
Research and Development AbbVie, FDA, Roche, clinical trials, multiple myeloma

The FDA has placed a partial clinical hold on studies of multiple myeloma treatment Venclexta/Venclyxto (venetoclax) following a number of …

FDA approves first-ever postpartum depression therapy: Sage Therapeutics’ Zulresso

March 20, 2019
Research and Development, Sales and Marketing FDA, Sage Therapeutics, depression, pharma, postpartum depression

The FDA has announced its decision to approve Sage Therapeutics’ intraveneous injection Zulresso (brexanolone), marking the first authorisation of a …

allergan

FDA approves first paediatric treatment for intra-abdominal and urinary tract infections in over 10 years

March 19, 2019
Manufacturing and Production, Sales and Marketing Allergan, Avycaz, FDA, pharma

Allergan has revealed that Avycaz (ceftazidime and avibactam) has been awarded an expansion of its label by the FDA to include …

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Purdue Pharma vow not to profit from fast tracked opioid overdose antidote

March 18, 2019
Sales and Marketing FDA, OxyContin, Purdue Pharma, nalmefene hydrochloride, opioids

The FDA has granted OxyContin drugmaker Purdue Pharma, fast track designation for opioid overdose antidote nalmefene hydrochloride (HCl) injection. However, …

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Top Ten most popular articles on Pharmafile.com this week!

March 15, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Acadia Pharmaceuticals, FDA, Sandoz, brexit, genomics, pharma, pharmacovigilance, top 10

The US Department of Justice has launched an investigation into the sales and marketing practices of San Diego firm Acadia …

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National Cancer Institute Director Ned Sharpless to become interim FDA Commissioner

March 13, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Ned Sharpless, Scott Gottlieb, appointment, pharma

Following the surprise resignation of current FDA Commissioner Dr Scott Gottlieb a week earlier, Dr Norman ‘Ned’ Sharpless, Director of …

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FDA approve valsartan generic after shortages of supply

March 13, 2019
Manufacturing and Production, Research and Development FDA, blood pressure drugs, cardiovascular, generic, valsartan

The FDA has approved a new generic version of blood pressure drug valsartan. The approval comes amid shortages in supply …

FDA advisory panel recommends Sanofi’s dengue vaccine in children, but rejects its use in adults

March 11, 2019
Sales and Marketing FDA, Sanofi, US, Vaccine, dengue, dengvaxia, pharma

Dengvaxia, Sanofi’s vaccine for dengue fever, has been burdened with further negative scrutiny after the FDA’s vaccine advisory panel passed …

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FDA Commissioner Scott Gottlieb announces resignation

March 8, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Scott Gottlieb, appointment, pharma

Dr Scott Gottlieb, the 23rd Commissioner of the US Food and Drug Administration (FDA), stoked surprise throughout the industry with …

allergan

Allergan’s depression drug rapastinel fails to outperform placebo at Phase 3

March 7, 2019
Research and Development Allergan, FDA, depression, major depressive disorder, pharma, rapastinel

As Janssen celebrated the FDA approval of the first novel therapy for depression in three decades with Spravato, Allergan released …

scott_gottlieb

FDA Commissioner Scott Gottlieb announces resignation

March 6, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Scott Gottlieb, opioid crisis, pharma

Dr Scott Gottlieb, the 23rd Commissioner of the US Food and Drug Administration (FDA), stoked surprise throughout the industry with …

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