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FDA Releases New Drug Safety Communication on Gabapentin, Pregabalin americanpharmaceuticalreview
December 23, 2019
The U.S. Food and Drug Administration (FDA) is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) ...
New Drug Application submitted for first-ever Progeria treatment europeanpharmaceuticalreview
December 23, 2019
A New Drug Application has been submitted to the FDA for lonafarnib, the first-ever treatment for Progeria and Progeroid Laminopathies.
FDA approves Astellas-Seattle Genetics’ bladder cancer drug pharmaceutical-technology
December 23, 2019
The US Food and Drug Administration (FDA) has granted accelerated approval to Astellas Pharma and Seattle Genetics’ Padcev drug to treat locally advanced or metastatic urothelial cancer.
Merck secures FDA authorisation for Ebola vaccine Ervebo pharmaceutical-technology
December 23, 2019
Merck (MSD) has received the US Food and Drug Administration (FDA) approval for its Ervebo vaccine to prevent Ebola virus disease (EVD) caused by Zaire ebolavirus.
FDA Advisory Committee votes unanimously to support use of teprotumumab to treat thyroid eye disease pharmaceutical-business-review
December 20, 2019
Horizon Therapeutics announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the US Food and Drug Administration (FDA) voted unanimously ...
Pfizer, Astellas secure expanded FDA approval for XTANDI pharmaceutical-business-review
December 20, 2019
Pfizer and Astellas Pharma have secured approval for a new indication for XTANDI (enzalutamide) from the US Food and Drug Administration (FDA) to include its use in ...
FDA Approves Padcev (enfortumab vedotin-ejfv) for Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer drugs
December 20, 2019
Astellas Pharma Inc. and Seattle Genetics, Inc. (Nasdaq:SGEN) announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Padcev™ for the treatment of ...
Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma drugs
December 20, 2019
Epizyme, Inc., a late-stage biopharmaceutical company developing novel epigenetic therapies, announced that it has submitted a New Drug Application (NDA) to ...
FDA Issues Warning Letter to Alkermes americanpharmaceuticalreview
December 19, 2019
The U.S. Food and Drug Administration (FDA) posted a warning letter to Alkermes of Massachusetts, for misbranding the drug Vivitrol (an extended-release injection formulation ...
Dr Stephen Hahn appointed as new FDA commissioner europeanpharmaceuticalreview
December 19, 2019
The US Food and Drug Administration (FDA) has been appointed its new commissioner, reports Reuters. Dr Stephen Hahn was confirmed as the new head of the regulatory body ...

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