Geron Corp., a company founded more than three decades ago, is finally celebrating its first U.S. FDA approval. The agency cleared imetelstat, branded Rytelo, for use in transfusion-dependent anemia in adults with low- to intermediate-risk myelodysplastic syndromes, specifically those requiring four or more red blood cell units over eight weeks who have failed or no longer respond to erythropoiesis-stimulating agents (ESA) or who are not eligible for ESA treatment.
The U.S. FDA clamped a full clinical hold Biomea Fusion Inc.‘s phase I/II study of BMF-219 for treating type 1 diabetes and type 2 diabetes. The hold sank the stock on June 7 as the company looked to find answers so it could sit down with the agency to discuss next steps.
Moon Surgical SAS recently received U.S. FDA clearance for the commercial version of its Maestro surgical robotic system for laparoscopic procedures. The greenlight is “pretty massive” for the company as it will allow the robotic platform to be rolled out in the U.S., to help enhance the surgeon’s performance while carrying out procedures, Anne Osdoit, CEO of Moon Surgical, told BioWorld.
Washington-based Vanda Pharmaceuticals Inc. has faced a challenging few years involving a federal lawsuit against the U.S. FDA, patent infringement litigation, increasing generic competition and dwindling sales, as well as a complete response letter nixing plans to expand its melatonin receptor agonist Hetlioz (tasimelteon) into insomnia, yet it has recently received a higher, unsolicited acquisition offer of $466 million from a second company, Cycle Pharmaceuticals Ltd.
Although the U.S. FDA unexpectedly sprang the news on Eli Lilly and Co. that it would hold an advisory committee meeting on the BLA for the company’s Alzheimer’s disease drug, donanemab, the agency’s briefing document for the June 10 meeting doesn’t appear to hold any surprises.
Medical device manufacturers based in China may feel the FDA has a bullseye on their backs, but two firms located in Canada were the subjects of recently posted FDA warning letters.
The discussion that preceded the June 4 U.S. FDA advisory committee vote against the approval of Lykos Therapeutics Inc.’s midomafetamine as a treatment for post-traumatic stress disorder could shine some light on the way forward for other sponsors developing psychedelics for approved medical use.
Molecular diagnostics company Genetic Signatures Ltd. is gearing up to launch its Easyscreen gastrointestinal parasite detection kit in the U.S. following its first FDA 510(k) clearance.
The saga of Illumina Inc.’s attempt to reacquire Grail Inc., seems to have come to an end with a capitulation to market regulatory authorities, but Illumina has chosen to spin off Menlo Park, Calif,-based Grail rather than sell the company outright.
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd. has received IND clearance in China by the National Medical Products Administration (NMPA) to conduct a phase I trial of its antibody-drug conjugate (ADC) FZ-AD005 for advanced solid tumors.
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