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Human Drugs

Amneal Recalls Contaminated Tablets

Amneal Pharmaceutical recalls three lots of sulfamethoxazole/trimethoprim tablets because they may exhibit black spots on their tablet surface due to ...

Human Drugs

Arvinas Files NDA for Breast Cancer Drug

Arvinas files an NDA for vepdegestrant for treating patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative ESR1-mu...

Medical Devices

Baxter Recalls Novum IQ Syringe Pump

Baxter recalls its Novum IQ large volume pump after becoming aware of the potential for underinfusion following use of the devices standby mode featur...

Human Drugs

House Subcommittee Advances FDA Budget Bill

A House Subcommittee markup votes along party lines to vote out and advance the agencys FY 2026 spending bill to the full committee.

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Human Drugs

FDA OKs Petition to Correct Phathom Patent Listing

FDA approves a Phathom Pharmaceuticals citizen petition that corrects an agency Orange Book listing to recognize 10 years of new chemical entity exclu...

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Human Drugs

FDA Platform Technology OK for Sarepta Vector

FDA grants platform technology designation to a Sarepta viral vector used in an investigational gene therapy to treat a form of muscular dystrophy.

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Human Drugs

New Safety-Related Hernia Mesh Label Recommendations

FDA posts a draft guidance entitled Hernia Mesh Package Labeling Recommendations.

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Human Drugs

Drug Labeling Improved for Pregnant Women: FDA

FDA confirms that all drugs now have updated labeling to better provide health risk information to pregnant women.

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Human Drugs

4 States Want Mifepristone REMS Ended

California, Massachusetts, New Jersey, and New York ask FDA to cancel the mifepristone REMS program requirements in their states or decline to enforce...

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FDA General

Makary Pushes for Reductions in Regulatory Barriers

FDA commissioner Marty Makary promises that the agency will listen to stakeholder ideas on reducing regulatory barriers and evolving its processes by ...