The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster ...
The US Food and Drug Administration is rolling out a new program to speed up drug reviews by emphasizing clearer, more frequent communication with companies, aided by a surge of new hires.
Specifically, sponsors will be able to submit a question via email and agency staff will aim to respond within three business days by email. Since the pilot launched in October, the agency has ...
Patent reforms could address a problem that’s been driving rising prescription drug costs and create a more competitive ...
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce ...
The "The FDA (Food and Drug Administration) Drug Approval Process Training Course (Feb 23rd - Feb 24th, 2026)" training has been added to ResearchAndMarkets.com's offering.
The FDA's fast track designation aims to expedite ITM-94's development for diagnosing clear cell renal cell carcinoma. The ...
The Associated Press on MSN
The FDA removes a long-standing warning from hormone-based menopause drugs
Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about ...
The Food and Drug Administration (FDA) granted traditional approval to Imdelltra (tarlatamab-dlle) for adult patients with ...
FDA sign & Bldg 21 at Entrance PHOTO COURTESY OF COMMONS.WIKIMEDIA.ORG Washington (AP) — Hormone based drugs used to treat ...
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