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Human Drugs

FDA OKs Glaxo Myeloma Therapy

FDA grants GlaxoSmithKline accelerated approval for Blenrep (belantamab mafodotin-blmf) for certain adult patients with relapsed or refractory multipl...

Human Drugs

Ferring Recalls Desmopressin Due to Superpotency Concerns

Ferring Pharmaceuticals recalls all lots of DDAVP (desmopressin) nasal spray 10 mcg/0.1mL, desmopressin acetate nasal spray 10 mcg/0.1mL, and Stimate ...

Biologics

Vaccine Decisions Based on Good Science, Data: Hahn

FDA commissioner Stephen Hahn uses a Washington Post op-ed to reassure the public that any Covid-19 authorized for widespread use will be thoroughly e...

Human Drugs

Eight Charged in Clinical Trial Fraud Scheme

The Justice Department says a federal grand injury has indicted eight people in a scheme to falsify FDA clinical trial data.

Biologics

Experts Weigh-in on Covid Vaccine Deployment

More than 250 scientific experts say FDA must thoroughly evaluate the completed Phase 3 trial results of any Covid-19 vaccine before the vaccine is ma...

Medical Devices

Covid Diagnostic Test Town Hall Scheduled

FDA has scheduled the next in a series of virtual town halls to answer questions on developing coronavirus diagnostic tests for 8/12.

Human Drugs

Trump Signing Order to Relocate Drug Manufacturing to U.S.

The White House says President Trump is signing an Executive Order to increase American production of essential medical supplies and cut down U.S. rel...

Medical Devices

Surmodics Sublime Radial Access PTA Catheter Cleared

FDA clears a Surmodics 510(k) for its Sublime Radial Access 0.014 Rapid Exchange percutaneous transluminal angioplasty dilatation catheter.

Federal Register

Info Collection on Extralabel Animal Drug Use

Federal Register notice: FDA seeks comments on an information collection entitled Extralabel Drug Use for Animals 21 CFR 530.

Human Drugs

DoJ Seeking $13 Billion for OxyContin Claims: Report

Reuters reports that the Justice Department is asking for nearly $13 billion to resolve charges against Purdue Pharma and its Sackler family owners.