Author name: Leonardo Arias

The agency says the CMS and MA organizations aren’t doing enough to screen durable medical equipment providers, especially out-of-network companies that aren’t enrolled in Medicare.

The FDA aims to leverage the expertise of qualified research institutions paired with drug sponsors to lessen the risk of clinical holds during the investigational new drug review process and expedite the path to first-in-human development in the U.S. The initial application period will close on Oct. 30.

GSK is consolidating its vaccine manufacturing operations to one site—located in Canada—amid what a spokesperson said is “decreasing demand” for egg-based flu shots.

The agency says the CMS and MA organizations aren’t doing enough to screen durable medical equipment providers, especially out-of-network companies that aren’t enrolled in Medicare.

After inking a T cell engager pact with Chimagen Biosciences a few years ago, GSK is back for more, this time acquiring a multiple myeloma program from the antibody specialist.

Analysts believe Cullinan Therapeutics and Taiho Oncology can overcome the safety risks as zipalertinib “sets [a] new bar” for first-line treatment of a type of lung cancer. The candidate is already under review for the the second-line setting, with a decision expected by early next year.

Safety and access were top of mind at Monday’s public hearing exploring the regulation of psychedelic therapies. “The medicine opens the door,” NeuroAlchemy co-founder Michaela Vogt said during the meeting, but many other factors will ensure this new drug class can benefit patients.

The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.

A principios del siglo XX, la ciencia tropezó con un límite físico que parecía infranqueable. La física clásica dictaba que ningún microscopio óptico, sin importar la calidad de sus lentes de cristal, podría revelar objetos más pe …

Durante décadas, la biología evolutiva estuvo dividida por una pregunta fundamental: ¿cuál es la unidad verdadera sobre la que actúa la selección natural? Mientras algunos teóricos defendían que la competencia ocurre estrictamente entre organis …