Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.
A top-line readout of the 26-week phase IIa Cbeyond trial showed nimacimab, Skye Bioscience Inc.’s peripherally restricted CB1 inhibitor antibody for weight loss, fell short of statistical significance as a monotherapy vs. placebo on the primary endpoint of weight loss, sending the company’s shares down 60%. Skye executives, however, offered a more optimistic outlook for the findings, which they said provide clear direction for moving forward.
In a deal that could bring more than $2.1 billion in payments to Arbor Biotechnologies Inc., 90-year-old Chiesi Group gained exclusive and global rights to develop and commercialize ABO-101 for primary hyperoxaluria type 1, an ultra-rare disease caused by a mutation in the AGXT gene, as well as an option to go after a limited number of additional targets.
Like a scene from a movie, a British beauty influencer and a German disabled war veteran could provide just the spark that Europe needs to open its financial heart to med-tech companies in need of love and cash. The Beauty Tech Group, which sells a range of U.S. FDA-cleared aesthetics devices popular with global influencers, raised £106.5 million ($144 million) in an IPO Oct. 3 on the beleaguered London Stock Exchange.
The U.S. FDA device center’s guidance agenda for fiscal 2026 is the classic case of something old and something new, but what was borrowed from FY 2025 may make some blue.
With U.S. President Donald Trump’s administration vocally opposed to abortion, the U.S. FDA has approved a new generic version of the pill that makes the procedure possible medically: mifepristone, once better known as RU-486.
The U.S. FDA has approved the priority sNDA for a new first-line maintenance therapy in extensive-stage small-cell lung cancer from Jazz Pharmaceuticals plc. Zepzelca (lurbinectedin) can now be combined with Tecentriq (atezolizumab, Roche AG) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Roche) as a maintenance therapy for adults who haven’t progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
Medtronic plc’s Brainsense adaptive deep brain stimulation system has been shown to be tolerable, effective and safe for long-term use at home in people with Parkinson’s disease. A study published in the Journal of the American Medical Association (JAMA) Neurology found that the majority of participants who received aDBS with the Percept neurostimulator achieved good ‘on-time’ without troublesome dyskinesia compared to standard continuous DBS therapy.
With a new drug available to slow the progression of type 1 diabetes, Sanofi SA is partnering with two med-tech companies to increase screening for early-stage type 1 diabetes and identify eligible patients.
Taho Pharmaceuticals Ltd. announced an NDA submission to the U.S. FDA for TAH-3311, developed as the world’s first oral dissolving film formulation of apixaban, marking a regulatory milestone for the Taipei-based biotech.
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