Zepbound’s clinical tests in obstructive sleep apnea showed improvement in breathing disruptions that were accompanied by reductions in body weight. The new approval gives the Eli Lilly medicine the opportunity to become a blockbuster seller in yet another indication.
Neurocrine Biosciences’ Crenessity is now FDA approved for treating classic congenital adrenal hyperplasia (CAH), a rare and potentially fatal endocrine disorder. The approval comes with a priority review voucher, which Neurocrine could sell for around $150 million.
The home care industry is booming. As Baby Boomers age and more families seek in-home solutions for loved ones, demand for home care services is at an all-time high.
The FDA cited deficiencies in govorestat’s application in galactosemia, a rare metabolic disease, Applied Therapeutics said. The biotech is still on track to submit a separate application for the drug in sorbitol dehydrogenase (SORD) deficiency, another rare disease that has no FDA-approved therapies.
BridgeBio Pharma claims its drug, Attruby, has an edge over a Pfizer drug as a treatment for cardiomyopathy caused by transthyretin-mediated amyloidosis. But new competition to both products could come soon from Alnylam Pharmaceuticals, now set to receive an FDA decision in this indication by late March.
A patient death in a clinical trial usually prompts the FDA to impose a clinical hold. But Neurogene is able to avoid a lengthy clinical trial pause largely because of its participation in an FDA pilot program intended to speed up the development of therapies for rare diseases.
Approval of Syndax’s Revuforj for acute leukemia makes the twice-daily pill the first in a new class of drugs that block a cancer-driving protein called menin. Other companies developing menin inhibitors include Kura Oncology, Biomea Fusion, and Johnson & Johnson subsidiary Janssen.
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Right to repair would undermine the FDA’s regulations and introduce unnecessary risk into the healthcare industry, threatening the high-quality care that doctors provide patients.
The PTC Therapeutics gene therapy, Kebilidi, treats an enzyme deficiency that affects the body’s ability to produce dopamine, a neurotransmitter important for motor control. FDA approval for the product comes two years after it won its first regulatory approvals in Europe.
Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.
The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. Use of this ingredient in cold and allergy medicines grew after a federal law required that pseudoephedrine-containing products be kept behind pharmacy counters.
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Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher. The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome.
Here is a selection of recent executive hires, exits, promotions and layoffs occurring across the healthcare industry.
After the FDA delayed the approval of MDMA-assisted therapy for PTSD, there's still a way forward for psychedelic medicines, experts said at HLTH.
The FDA had asked Biogen and Sage Therapeutics to provide more clinical data supporting Zurzuvae in major depressive disorder. Citing the time and expense of additional clinical trials, the partners decided against further development in this indication
Large language models will soon become a much bigger part of doctors’ clinical workflows, former FDA Commissioner Scott Gottlieb said Tuesday at the 3rd Annual Summit on the Future of Rural Health Care.