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FDA approves magnetic brain-zapping helmet to treat OCD sufferers who don't respond to therapy or drugs dailymail
September 04, 2018
A brain 'zapping' device was approved to treat obsessive compulsive disorder by the US Food and Drug Administration (FDA).
Drugs Approved by FDA Expected to Exceed 50 in 2018 1℃
September 04, 2018
More than half of 2018 is already over. FDA has approved the marketing of 30 drugs by August 11, 2018.
FDA Releases Statement on Valsartan Investigation americanpharmaceuticalreview
September 03, 2018
Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one medication, valsartan, contain an impurity that doesn’t meet FDA’s safety standards. Valsartan is an angiotensin II receptor b
FDA Issues Complete Response Letter for NDA for Dasotraline americanpharmaceuticalreview
September 03, 2018
Sunovion Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatme
Bayer Receives FDA Approval for Jivi americanpharmaceuticalreview
August 31, 2018
Bayer announced the U.S. Food and Drug Administration (FDA) has approved Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of
Cadila gets five observations from US FDA expressbpd
August 30, 2018
Cadila Healthcare said the US health regulator has issued five observations after inspection of its subsidiary Liva Pharmaceuticals’ injectables manufacturing facility. “This was a product specific pre-approval inspection.......
Statement by FDA Commissioner on Agency's Work to Address Opioid Crisis americanpharmaceuticalreview
August 30, 2018
Over the past 17 months, we've set out to address the opioid crisis forcefully, using all the agency's tools and authorities.
ReflectionBio Receives Orphan Drug Designation from FDA americanpharmaceuticalreview
August 29, 2018
Reflection Biotechnologies Limited (ReflectionBio) announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ReflectionBio's RBIO-101 program (AAV.CYP4V2), an AAV-based gene therapy product for treating Bietti's Crystall
FDA Approves Imbruvica Plus Rituximab americanpharmaceuticalreview
August 28, 2018
Janssen Pharmaceutical announced the U.S. Food and Drug Administration (FDA) approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM), a rare blood cancer.
Novasep Announces Successful FDA Inspection contractpharma
August 28, 2018
Novasep has announced that its API development and manufacturing site in Chasse-sur-Rhône, France, has been successfully inspected by the US Food and Drug Administration.

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