The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted Jan. 14, and dated between Dec. 6 and Dec. 19, 2024, but otherwise seem to have little in common.
The U.S. FDA approved 19 drugs in December, an increase from 10 in November. In total, 228 FDA approvals were granted in 2024, averaging 19 per month. Seven new molecular entities were approved in December, bringing the year's total to 49.
Neomorph Inc. has signed another billion-dollar deal to develop molecular glue degraders, this time with Abbvie Inc. It’s the third agreement in the past year the five-year-old company has signed with big pharma companies in a space with lots of collaborative deals.
With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.
Beta Bionics Inc. kicked off the new year with plans for an initial public offering of 7.5 million shares “as soon as practicable.” Expected to be priced at $14 to $16 per share, the IPO would gross $105 million to $120 million for the insulin delivery device maker.
In a boon for companies developing brain-computer interface (BCI) technologies, researchers have used a BCI and artificial intelligence to restore touch sensations in a bionic arm.
The backlog of requests for Medicare national coverage analyses is a matter of record, but a new analysis highlights how deep that backlog runs. CMS declared it will review a petition from Impulse Dynamics to consider coverage of cardiac contractility modulation, responding to a request the company filed more than two and a half years ago.
To realize the promise of cell therapy for neurodegenerative disorders, S.Biomedics Co. Ltd. is looking to expand clinical trials of TED-A9, its stem cell therapy for Parkinson’s disease (PD), to the U.S., having reaped positive results from a domestic phase I/IIa trial in November 2024.
A year after its $175 million IPO in 2024, Arrivent Biopharma Inc. picked up rights to develop and commercialize Lepu Biopharma Co. Ltd.’s antibody-drug conjugate (ADC) candidate, MRG-007, worldwide excluding the greater China region.
Medexus Pharmaceuticals Inc. looks set for its U.S. launch of bifunctional alkylating agent treosulfan in the first half of 2025 following a long-awaited FDA approval of the drug, branded Grafapex, for use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults and pediatric patients, 1 and older, with acute myeloid leukemia or myelodysplastic syndrome.