FDA's plan to phase out animal testing may hurt Charles River's revenues. The DCF model suggests that CRL presents an ...

In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, ...

The Stanley Brothers created Charlotte's Web, the CBD supplement that’s worked wonders on seizures. Now they are developing ...

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

The FDA's new genAI-assisted scientific review technology, named Elsa, was officially adopted by the agency on 2 June.

Pharmacoequity requires policies geared at equitable access to the right medicine for all individuals — regardless of race, ethnicity or socioeconomic status. This should be our north star.

The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one to two months for companies it says are backing national interests.

The FDA approved Zegfrovy for advanced non-small cell lung cancer with EGFR exon 20 mutations after chemotherapy.

It is the only ready-to-use liquid immunoglobulin therapy with (IgA) content and is set for commercialization in 2026.

MIAMI, FL / ACCESS Newswire / June 25, 2025 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage privately-held ...

Regulatory Milestone Underscores Urgency and Promise of First-in-Class Mitochondrial Cell TherapyHaifa, ISRAEL, June 30, 2025 (GLOBE NEWSWIRE) -- Minovia Therapeutics Ltd. (“Minovia” or the “Company”) ...

The Food and Drug Administration has gone all in on AI since Martin Makary, M.D., took over the agency, most recently demonstrated by the coronation of new generative AI tool Elsa. Now, Makary and ...