Physio Solutions, which does business as medlitix, is the 17th company certified to settle out-of-network payment disputes under the No Surprises Act as arbiters face increasing scrutiny from researchers and lawmakers.
HHS adds new IDR entity as surprise billing disputes surge Read More »
Gaining authorization for transvaginal gynecologic procedures expands the list of indications for da Vinci SP in Europe.
Intuitive single-port robot earns CE mark for new indication Read More »
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.
OIG urges crackdown on equipment suppliers in Medicare Advantage Read More »
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.
FDA opens Operation TrialBlazer for applications, hoping to reshore early trials Read More »
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.
GSK lays off 650 staffers amid closure of German vaccine manufacturing site Read More »
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.
OIG urges crackdown on equipment suppliers in Medicare Advantage Read More »
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.
GSK bags Chimagen’s trispecific T cell engager in deal worth up to $750M Read More »
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.
