FDA

Showing 15 posts of 1442 posts found.

iran

Iran ready to export medicines to Venezuela

February 25, 2019
Sales and Marketing FDA, Iran, Venezuela, biotech, global, pharma

The chairman of the Iranian Food and Drug Administration (FDA) Mehdi Pirsalehi, has said that Iran is ready to export …

FDA halts Xencor’s acute myeloid leukaemia trial following two patient deaths

February 21, 2019
Research and Development Cancer, FDA, Xencor, leukaemia, pharma

Cancer biopharma firm Xencor has revealed it is to place a hold on its ongoing Phase 1 trial of XmAb14045, …

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

February 15, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AMR, Dame Sally Davies, FDA, FMD, antibiotic resistance, esketamine, falsified medicines, top 10

News that the FDA’s advisory panel had recommended Janssen’s intranasal esketamine spray Spravato as a treatment for treatment resistant depression, …

FDA approves Novartis’ Egaten for parasitic infection fascioliasis

February 14, 2019
Sales and Marketing Egaten, FDA, Novartis, fascioliasis, pharma

The FDA has taken the decision to authorise the use of Novartis’ Egaten (triclabendazole) in patients older than six years …

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Janssen’s esketamine drug recommended by FDA panel for depression

February 13, 2019
Research and Development, Sales and Marketing FDA, Janssen, Spravato, depression, esketamine, major depressive disorder, pharma

In a rare and welcomed development in the treatment of major depressive disorder (MDD), Janssen has announced that its esketamine …

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FDA to crack down on dietary supplements

February 12, 2019
Manufacturing and Production Alzheimer's, Alzheimers, Cancer, Dietary Supplements, FDA, USA, diabetes

The FDA is cracking down on those selling ‘dietary supplements’, having sent warning letters to companies who claim, without proof, …

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FDA warns over breast implant cancer risk after nine deaths confirmed

February 8, 2019
Medical Communications, Research and Development Cancer, FDA, breast implants, pharma

The FDA has warned against the link between breast implants and anaplastic large cell lymphoma, noting that at least nine …

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

February 8, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, GSK, Merck, Pfizer, falsified medicines, strike, top 10

The strike in Ireland featured twice in this week’s top 10 after Pfizer employees in County Cork lost a dispute …

FDA approves first therapy for acquired thrombotic thrombocytopenic purpura: Sanofi’s Cablivi

February 7, 2019
Sales and Marketing Calblivi, FDA, Sanofi, acquired thrombotic thrombocytopenic purpura, pharma

Following swiftly on the heels of the previous success with the announcement of positive Phase 3 data for Icaria in …

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AstraZeneca scores accelerated approval in US and Europe for respiratory syncytial virus drug

February 5, 2019
Manufacturing and Production, Research and Development, Sales and Marketing AstraZeneca, EMA, FDA, MEDI8897, pharma, respiratory syncytial virus

It’s a double victory for AstraZeneca as the company announced its F monoclonal antibody MEDI8897 has been granted accelerated review …

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FDA knocks back Alkermes’ opioid-based depression therapy over lack of evidence

February 4, 2019
Sales and Marketing Alkermes, FDA, major depressive disorder, pharma, rejection

Alkermes experimental opioid-based depression therapy ALKS 5461 has been rejected by the FDA, it has emerged, in the adjunctive treatment …

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Mylan’s Wixela becomes first FDA-approved generic version of GSK’s Advair inhaler

January 31, 2019
Sales and Marketing Advair, COPD, FDA, Wixela, asthma, generic, pharma

Mylan’s Wixela has become the first generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler to …

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Head of opioid advisory panel criticises FDA for complacency in ongoing crisis

January 28, 2019
Medical Communications, Sales and Marketing Dsuvia, FDA, opioid crisis, opioids, pharma

The opioid crisis continues to be a top healthcare concern in the US, but the head of the FDA’s Anesthetic …

samsung

FDA approves third Herceptin biosimilar with Samsung Bioepis’ Ontruzant

January 22, 2019
Manufacturing and Production, Sales and Marketing FDA, Herceptin, Samsung Bioepis, biosimilar, pharma

Samsung Bioepis’ has announced that the FDA has chosen to approve Ontruzant (trastuzumab-dttb), its biosimilar version of Roche’s Herceptin (trastuzumab), …

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US regulator to recruit 50 new gene and cell therapy clinical reviewers

January 16, 2019
Research and Development FDA, cell therapy, gene therapy, regulation

FDA Commissioner Scott Gottlieb has said that the agency hopes to recruit 50 additional clinical reviewers for the group that …

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