Boston Scientific Corp. racked up a two-fer from the U.S. FDA with approval of its navigation-enabled Farawave Nav ablation catheter and 510(k) clearance for the Faraview software for use with its Farapulse pulsed field ablation (PFA) system.
Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
With fresh phase II ovarian cancer data in hand, Verastem Oncology Inc. plans to file an NDA by the end of the month for its avutometinib and defactinib combination treatment. The NDA will be for adults who have recurrent KRAS mutant recurrent low-grade serous ovarian cancer, a direction that may have caused the stock to wilt.
The U.S. FDA approved 23 drugs in September, up from 22 in August and 17 in July, bringing the 2024 monthly average to nearly 20. This surpasses last year's 16 per month, 12.5 in 2022, and 17 per month in both 2021 and 2020.
The speculation as to the status of Michelle Tarver, the acting director of the U.S. FDA’s device center, is officially over despite disclaimers at. The outgoing director, Jeff Shuren, said Tarver “will make a great center director” in remarks during an Oct. 17 public appearance, thus cementing Tarver’s role at FDA.
Nowdiagnostics Inc. established an exclusive agreement with Labcorp Holdings Inc. for distribution of its First To Know syphilis test in the U.S. The test provides results in 15 minutes with as little as a single drop of blood. The test will be available to hospitals and clinicians by the end of 2024 and offered to patients directly through Labcorp Ondemand in 2025.
U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies.
With two complete response letters in the rearview mirror, Abbvie Inc.’s Vyalev (foscarbidopa/foslevodopa) has been approved by the U.S. FDA for treating Parkinson’s disease. The drug is the first subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in adults with advanced disease.
Clarity Pharmaceuticals Ltd. will begin early next year its pivotal phase III trial for its copper-based radiopharmaceutical, 64Cu-SAR-bisPSMA, for diagnosing prostate cancer in patients with biochemical recurrence following positive U.S. FDA feedback.
Medtronic plc received U.S. FDA approval to undertake an early feasibility study of its dual-energy Affera cardiac ablation system in sustained ventricular tachycardia. Affera combines both radiofrequency and pulsed field ablation technologies in the Sphere-9 catheter along with high-density mapping.
RSS
