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MicroVention Announces FDA Premarket Approval of New Flow Diverter americanpharmaceuticalreview
January 15, 2020
MicroVention announced the FDA Premarket Approval (PMA) for the FRED® (Flow Re-Direction Endoluminal Device) device for the treatment of brain aneurysms.
FDA grants Avatrombopag Orphan Drug Designation for thrombocytopenia europeanpharmaceuticalreview
January 15, 2020
The US FDA has granted avatrombopag (Doptelet) ODD as around 10 percent of US cancer patients per year experience chemotherapy-induced thrombocytopenia (CIT) with no available treatment.
FDA grants priority review for AstraZeneca’s Lynparza pharmaceutical-technology
January 15, 2020
The US Food and Drug Administration (FDA) has granted priority review for Lynparza (olaparib) in combination with bevacizumab to treat advanced ovarian cancer.
FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment drugs
January 14, 2020
Neurelis, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizure
FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors worldpharmanews
January 14, 2020
The U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST
Nabriva Receives FDA Acknowledgement of NDA Resubmission for CONTEPO americanpharmaceuticalreview
January 14, 2020
Nabriva Therapeutics announced the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its New Drug Application (NDA) resubmission for marketing approval of CONTEPO™ (fosfomycin) for injection for ...
FDA approves Keytruda for patients with high-risk, non-muscle invasive bladder cancer europeanpharmaceuticalreview
January 14, 2020
Keytruda is the first anti-PD-1 monoclonal antibody therapy approved for patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer.
3Derm Announces Two FDA Breakthrough Device Designations for Autonomous Skin Cancer AI americanpharmaceuticalreview
January 13, 2020
3Derm Systems has been granted two FDA Breakthrough Device designations for 3DermSpot, an algorithm that uses artificial intelligence (AI) and highly standardized skin images to autonomously detect melanoma, squamous cell carcinoma, and basal cell carcino
Aruvant Receives FDA Rare Pediatric Disease Designation for Sickle Cell Treatment americanpharmaceuticalreview
January 13, 2020
Aruvant announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to ARU-1801, Aruvant's investigational therapy for the treatment of sickle cell disease.
FDA announces one nizatidine and two ranitidine voluntary recalls europeanpharmaceuticalreview
January 13, 2020
The US Food and Drug Administration (FDA) has announced that two companies are voluntarily recalling batches of ranitidine tablets and one company is voluntarily recalling lots of nizatidine tablets in the US.

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