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Human Drugs

Watchdog Blasts FDA Over Rising Costs, Higher Rejections

An advocacy group takes aim at FDA, arguing in a new report that the agencys drug review process has grown more costly and restrictive.

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Human Drugs

Kodiaks Zenkuda Posts 2nd Phase 3 Win in Diabetic Retinopathy

Kodiak Sciences says its anti-VEGF therapy Zenkuda (tarcocimab tedromer) hit the mark in a second Phase 3 trial in diabetic retinopathy.

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Human Drugs

Experts Highlight FDAs Push for Bespoke Genetic Therapy Pathway

Health experts breakdown a new FDA policy framework that could mark a turning point for highly individualized genetic medicines.

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Medical Devices

Multiple Violations at Longhorn Vaccines and Diagnostics

FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device Reporting, and Adulterated and Misbranded Device v...

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Human Drugs

FDA Asks for Rezolutes Ersodetug Data After Trial Miss

FDA asks to look at Rezolutes Phase 3 data after the companys trial of ersodetug missed the primary endpoint, with the hope of charting a clear path f...

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Human Drugs

FDA Open to Single Phase 3 for Netherton Syndrome Drug

Quoin Pharmaceuticals says FDA has signaled openness to a streamlined development path for its rare disease candidate QRX003, indicating that a single...

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Human Drugs

Beam Eyes Accelerated Approval for Genetic Disease Therapy

Beam Therapeutics says it will advance its base-editing therapy BEAM-302 into pivotal development to seek accelerated approval for treating Alpha-1 An...

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Human Drugs

4 Observations on Micro Labs 483

FDA releases the form FDA-483 issued following an inspection at the Micro Labs drug manufacturing facility in Bengaluru, Karnataka, India.

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Human Drugs

Corcepts Lifyorli Combo in Platinum-Resistant Ovarian Cancer Approved

FDA approves Corcept Therapeuticss cortisol-modulating drug Lifyorli (relacorilant) in combination with nab-paclitaxel for patients with platinum-resi...

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Human Drugs

HELP Republican Senators Urge FDA Mifepristone Action

Five Republicans on the Senate HELP Committee urge FDA to crack down on companies they say are illegally selling chemical abortion drugs in the U.S.