FDA Related News

Human Drugs

Adamis Pharmaceuticals NDA for Naloxone Copy

Adamis Pharmaceuticals files a 505(b)(2) NDA for its naloxone pre-filled single dose syringe product candidate, indicated for treating opioid overdose...

Human Drugs

Petition Partially Granted for Linzess Bioequivalence

FDA partially grants an Allergan petition seeking added bioequivalence assurances for irritable bowel syndrome drug Linzess (linaclotide).

Medical Devices

2 More Steps for Medical Device Innovation

FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren describe two additional FDA actions to spur medical device innovation.

Human Drugs

FDA Updates Generic Drug List

FDA issues the latest six-month update of its list of off-patent, off-exclusivity drugs without an approved generic.

Human Drugs

Acceptable ARB Nitrosamine Impurity Levels

FDA posts interim acceptable levels of nitrosamine impurities in angiotensin II receptor blockers.

Human Drugs

FDA Approves Herzuma, Biosimilar Herceptin

FDA approves Celltrions Herzuma, a biosimilar breast cancer drug for Genentechs Herceptin.

Human Drugs

FDA Finalizes Cancer Trial Endpoints Guidance

FDA finalizes a 2007 guidance on endpoints for drug and biologic cancer trials.

Human Drugs

FDA Approves Stemlines Elzonris for Rare Blood Disease

FDA approves Stemline Therapeutics Elzonris for treating blastic plasmacytoid dendritic cell neoplasm.

Pull Ad Drug Price Disclosure Proposal: WLF

Washington Legal Foundation says CMS should withdraw its proposal to require drug companies to include pricing information in DTC television ads becau...

Animal Drugs

Sales of Food Animal Antimicrobial Drugs Down: Gottlieb

FDA commissioner Scott Gottlieb says the agencys 2017 report on antimicrobial sales/distribution for use in food animals shows that efforts to signifi...