The FDA awards a second round of Commissioner’s National Priority vouchers to six larger biopharma companies. And this time, ...
The FDA’s new Commissioner’s National Priority Voucher signals a transformative shift in U.S. drug review, tying accelerated approval to manufacturing readiness, domestic supply-chain strength, and ...
On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and ...
The announcement comes on the heels of a deal with the Trump administration to expand access to weight-loss drugs and reduce ...
Linvoseltamab and sunvozertinib received FDA approval for multiple myeloma and non-small cell lung cancer, respectively, based on robust clinical trial data. Sebetralstat offers a new oral on-demand ...
HealthDay on MSN
FDA to Ease Copycat Drug Rules, Speeding Access to Cheaper Drugs
The US Food and Drug Administration (FDA) announced Wednesday that it will relax certain rules for approving low-cost versions of some high-priced medications, in an effort to speed up access to ...
Q3 2025 Management View CEO Sean Nolan stated, “The recent regulatory clarity and progress we've achieved, which was enabled ...
BioRestorative Therapies, Inc. ('BioRestorative”, 'BRTX” or the 'Company”) (NASDAQ:BRTX), a regenerative medicine innovator ...
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