Human Drugs
5 Observations in Glenmark Inspection
FDA releases the FDA-483 issued following an inspection at Indias Glenmark Pharmaceuticals.
Human Drugs
Partner Therapeutics Drug Approved for Radiation Sickness
FDA approves a Partner Therapeutics NDA for leukine for treating adult and pediatric patients acutely exposed to myelosuppressive doses of radiation.
Human Drugs
Amag NDA for Hypoactive Sexual Desire Disorder Drug
FDA accepts an Amag Pharmaceuticals NDA for bremelanotide, a first-in-class melanocortin 4 receptor agonist for treating hypoactive sexual desire diso...
Medical Devices
FDA Clears Rodo Medical Smilekey Induction Remover
FDA clears a Rodo Medical 510(k) for the Rodo Smilekey, an induction remover device for use with the Rodo Abutment System.
Human Drugs
Generic Drug Savings $8.8 Billion in 2017: FDA
FDA estimates 2017 generic drug approval cost-savings at $8.8 billion.
Human Drugs
CGMP Violations in Kolmar Korea Co. Inspection
FDA warns South Koreas Kolmar Korea Co. about CGMP violations in its production of finished pharmaceuticals.
Stop Selling Illegal Opioids, FDA Warns Online Nets
FDA warns operators of 53 Web sites to stop illegally selling opioids.
Human Drugs
IDT Australia Inspection Finds Multiple CGMP Issues
FDA warns IDA Australia about CGMP deviations and violations in its production of active pharmaceutical ingredients and finished drugs.
Human Drugs
Genentech sBLA for Hemlibra Gains Priority Review
FDA accepts for priority review a Genentech supplemental BLA for Hemlibra (emicizumab-kxwh) for adults and children with hemophilia A without factor V...
Human Drugs
Lilly Gains Approval for Alimta/Keytruda/Carboplatin Combo
FDA approves Eli Lillys Alimta (pemetrexed for injection) in combination with carboplatin and Mercks Keytruda (pembrolizumab) for the initial treatmen...
