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Human Drugs

FDA OKs Expanded Use of Furoscix

FDA approves a scPharmaceuticals supplemental NDA for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patien...

Human Drugs

Opportunities for Drug Development Dynamic Tools

FDA reports on a 2024 workshop on using dynamic tools to enhance new drug development efficiency.

Medical Devices

2 FDA Designations for Phantom Neuro Platform

FDA approves both Breakthrough Device and Targeted Acceleration Pathway designations for Phantom Neuros Phantom X platform that controls prosthetic li...

FDA General

Makary Pledges FDA Staff Assessment Due to Firings

FDA commissioner-nominee Marty Makary pledges during his confirmation hearing to do an independent assessment on personnel before recommending if any ...

Medical Devices

Baxter Infusion Pump Issue Early Alert

FDA issues a medical device early alert on a Baxter recall of specified Spectrum infusion pumps.

FDA General

DOGE-Targeted FDA Lab to Remain Open

The Trump Administration reverses an Elon Musk decision to terminate the lease of a 52,000 square foot major FDA laboratory in St. Louis, MO.

Human Drugs

Orphan Drug Designation for Farons Bexmarilimab

FDA grants orphan drug designation to Farons bexmarilimab to treat myelodysplastic syndrome.

Biologics

Roche Files sBLA for Gazyva in Lupus

FDA accepts for review a supplemental BLA for Gazyva (obinutuzumab) for treating lupus nephritis.

Animal Drugs

Indian-Made Generics Have Higher Risk: Study

An Ohio State University business school study finds that generic drugs made in India are 54% more likely to be associated with serious adverse events...

Animal Drugs

FDA Clinical Hold on BioNTech Malaria Vaccine

FDA places a clinical hold on BioNTechs Phase 1/2a dose escalation clinical trial evaluating an investigational RNA-based vaccine (BNT165e) for preven...