FDA actions, approvals, policy shifts, and compliance—how rules change timelines and probability.
Juul Labs received federal permission to sell Juul2, an updated e-cigarette with an optional app-based age-verification feature. The decision lets the company launch a new device and revised tobacco- and menthol-flavored cartridges after years of litigation, layoffs and market-share loss.
Juul Labs received federal permission to sell Juul2, an updated e-cigarette with an optional app-based age-verification feature. The decision lets the company launch a new device and revised tobacco- and menthol-flavored cartridges after years of litigation, layoffs and market-share loss.
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The FDA approved Mounjaro to reduce cardiovascular risk in adults with type 2 diabetes at high risk for heart attack, stroke or cardiovascular death. The decision gives Eli Lilly a cardiovascular label in a market where Novo Nordisk had already established a lead with semaglutide.
Newly obtained documents conflict with Robert F. Kennedy Jr.'s statements to lawmakers that his 2019 Samoa trip had nothing to do with vaccines. The dispute matters beyond the trip itself because it cuts into the trust basis on which some senators backed his confirmation.
Hospital leaders are pursuing a long-shot effort to delay, soften or partially reverse nearly $1 trillion in Medicaid cuts built into President Trump’s tax cut law. The strategy mixes immediate pressure for carveouts and payment offsets with a longer political bet on future Democratic gains.
A BioSpace roundup highlighted three separate signals: Capricor’s Duchenne muscular dystrophy review remains active after a three-month FDA extension, Moderna and Merck posted an early Phase 3 melanoma vaccine readout, and Heidi Overton emerged as President Donald Trump’s pick for permanent FDA leadership. Together they point to a market still trading heavily on regulatory timing and leadership stability.
Vitruvias Therapeutics is recalling 3,655 units from a single lot of generic Thyroid Tablets, USP 30 mg, after testing confirmed the potential for superpotency. The company also states on its website that it has ceased operations and transferred its products to H2-Pharma.
The FDA is reportedly weighing two new deputy commissioner posts, one focused on health and AI and another on drugs. The proposal is not final, but it would add structure to an agency still operating with several top roles filled on an acting basis.
Turkish antitrust regulators are investigating Teva over allegations that it manipulated the patent system and made misleading statements about rival medicines. The probe adds another competition challenge tied to conduct that a Teva spokesperson said is similar to the company’s European Commission case over Copaxone.
Pennsylvania reported two measles deaths in unvaccinated Lancaster County residents, the first U.S. deaths from the virus this year. The announcement lands amid the country’s highest measles case count since 1991 and a renewed fight over vaccination policy and public messaging.
Capricor said the FDA extended its review of deramiocel to Nov. 22 after the company submitted a major amendment with 24-month open-label extension data and a refined proposed indication focused on upper limb function. The move keeps the Duchenne muscular dystrophy cell therapy under active review after a 9-3 advisory committee vote against approval late last month.
The Food and Drug Administration is developing a plan for regulating medical devices that use generative artificial intelligence, according to Rick Abramson, director of the agency’s Digital Health Center of Excellence. He said the agency’s goal is formal policy guidance, including both broad and narrower topic-specific documents.
