The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public insight into the reasons new drug and biologics applications got rejected.
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’ Read More »
The agency’s decision supports broader access to a minimally invasive treatment for patients with severe tricuspid regurgitation, in which blood can leak backward into the heart.
Abbott gains national CMS coverage for tricuspid valve repair Read More »
Longtime insurance executive Mike Cotton will helm the company’s Medicaid division, while Bobby Hunter is stepping up as CEO of government programs.
UnitedHealth names new chief of government programs, Medicaid unit Read More »
The deal, which involves a $700 million upfront payment, gives AbbVie access to ISB 2001, a clinical-stage first-in-class trispecific antibody currently being tested for certain kinds of multiple myeloma as well as autoimmune indications.
AbbVie Scoops Up Ichnos Glenmark’s Lead Myeloma Antibody for Nearly $2B Read More »
The purchase of the Providence spinoff bolsters Samsung’s push to unify health data, including through wearables like the electronics giant’s Galaxy Watch line.
In this episode presented by Eclipsebio, BioSpace’s head of insights Lori Ellis discusses mRNA and srRNA with Andy Geall of Replicate Bioscience and Alliance for mRNA Medicines, and Pad Chivukula of Arcturus Therapeutics.
Partners Ultragenyx and Mereo BioPharma saw their stocks drop by 21% and 30%, respectively, after announcing that the Phase II/III study of their osteogenesis imperfecta candidate will proceed to final analysis, implying it did not show sufficiently strong results at an interim analysis.
A judge agreed that the CMS should recalculate the scores for one Alignment plan in Arizona. Now, all of the insurer’s MA members are in plans rated four stars or higher.
Alignment Healthcare wins partial victory in Medicare Advantage star ratings case Read More »
Aunque no es uno de los metales más abundantes en la corteza terrestre (el aluminio sigue siendo el principal), sí es muy frecuente. Los antiguos griegos y romanos ya conocían la existencia del plomo, un material pesado y azulado cuyo bajo punto de fusión lo hace tan popu …
Reciclar el plomo de las baterías de los coches es una realidad que salva vidas Read More »
The Global Fund to Fight AIDS, Tuberculosis and Malaria will work with Gilead and other private backers to ensure the HIV preventive Yeztugo, approved last month by the FDA, is available in low- and middle-income countries, concurrent with high-income nations.
