Key Takeaways In legislation enacted on Feb. 3, 2026, Congress reauthorized the rare pediatric disease priority review voucher program, clarified the scope of orphan drug exclusivity (ODE) and ...
A system that allows drug makers to profit from restricted access will never liberalize on its own—and patients will continue ...
Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.
The FDA has “proactively” granted Johnson & Johnson a coveted speedy review under the Commissioner’s National Priority Voucher pilot (CNPV), the agency said Monday. The voucher was granted to J&J for ...
Below is a review of novel drug and biological products approved by the Food and Drug Administration ( FDA) in 2025. The list includes several groundbreaking therapies that are expected to change the ...
Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
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