For the roughly 4,000 to 5,000 Americans diagnosed with mantle cell lymphoma each year, running out of treatment options can happen fast. The cancer is one of the more aggressive forms of non-Hodgkin ...
The US Food and Drug Administration (FDA) on Thursday issued draft guidance that would replace the accelerated approval portion of its broader guidance covering its various expedited pathways to ...
Outlook Therapeutics, Inc. OTLK shares are trading higher Tuesday after the company announced that the U.S. Food and Drug ...
ST. LOUIS — A newly FDA-approved procedure allows patients to regrow their own knee cartilage using autologous cell implantation. The treatment, known as MACI (Matrix Autologous Chondrocyte ...
Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians aligned with ...
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products authorized in the European Union or United States.
FDA accelerated approval covers relapsed/refractory MCL after ≥2 lines including a BTK inhibitor, positioning sonrotoclax as ...
NPR's Leila Fadel asks Mitch Zeller, former director of the FDA's Center for Tobacco Products, about the agency's approval of fruit-flavored electronic cigarettes.