FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...
National Law Review

New FDA Drug Reforms: Congress Extends Voucher Incentive, Clarifies Orphan Exclusivity and Provides Greater Transparency for Q1/Q2 Generic Approvals

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 ...
Psychology Today

What's Going on With Generic Stimulants?

I open my emails to find yet another message from a patient about their amphetamine-dextroamphetamine (the generic form of Aderall) no longer working. Dr. Plutchik, my meds no longer seem to be ...
Law

Fed. Judge Approves $200M Settlement With 2 Generic Drug-Pricing MDL Defendants

U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania granted final approval of a $200 million settlement between end-payer plaintiffs and Sun Pharmaceutical Industries and Taro ...
Reuters

Drugmakers turn to AI to speed trials, regulatory submissions

SAN FRANCISCO, Jan 26 (Reuters) - Artificial intelligence has yet to deliver on the most challenging aspect of drug development -- finding new molecules that lead to major medical advances -- but it ...
RealClearMarkets

Let's Not Allow Politics To Break the Generic Drug Market

Generic drugs are the rare part of American health care that actually drives down costs. In 2024, they accounted for 90 percent of all prescriptions filled in the United States yet accounted for only ...
Reuters

Indian drugmakers get regulatory nod to sell generic Wegovy, heating obesity‑drug race

The companies, which are yet to announce the approval, did not immediately respond to Reuters' request for a comment. Sun Pharma, which is India's largest drugmaker by revenue, on Friday announced ...