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FDA Says Viberzi (eluxadoline) has an Increased Risk of Serious Pancreatitis in Patients without a G americanpharmaceuticalreview
March 17, 2017
The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder.
GSK submits application to FDA for expanded indication of influenza vaccine pharmaceutical-technology
March 17, 2017
UK's GlaxoSmithKline (GSK) has submitted a supplemental biologics licence application (sBLA) to the US Food and Drug Administration (FDA) for expanded indication of its influenza vaccine, Fluarix Quadrivalent.
FDA panel says benefits of Endo's Opana ER no longer outweigh risks firstwordpharma
March 16, 2017
An FDA advisory committee voted 18 to eight with one abstention that the benefits of Endo International's reformulated Opana ER (oxymorphone) no longer outweigh its risks.
US FDA to lift import alert on Mohali plant financialexpress
March 16, 2017
The move will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market
FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL) drugs.com
March 15, 2017
Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL).
FDA Approves Kisqali drugs.com
March 14, 2017
The US Food and Drug Administration (FDA) has approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy...
Sunovion Submits sNDA to FDA for Use of APTIOM® for the Treatment of Partial-Onset Seizures in Child americanpharmaceuticalreview
March 14, 2017
Sunovion Pharmaceuticals has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication for its antiepileptic drug (AED) APTIOM® (eslicarbazepine acetate) to include use as monotherapy or a
FDA accepts the biologics license application for Avelumab for the treatment of metastatic urothelia pharmaasia
March 14, 2017
Merck and Pfizer announced that the US Food and Drug Administration has accepted for Priority Review the Biologics License Application for avelumab
Novartis’ Kisqali® Receives FDA Approval as First-Line Treatment for HR+/HER2- Metastatic Breast Can americanpharmaceuticalreview
March 14, 2017
The US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, huma
FDA grants orphan drug designation to Boehringer Ingelheim’s antibody BI 836858 pharmaceutical-technology
March 14, 2017
The US Food and Drug Administration (FDA) has granted orphan drug designation to Boehringer Ingelheim’s anti-CD33 ...

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