The Trump administration announced a proposed rule requiring food companies to notify the FDA when introducing new additives under the 'generally recognized as safe' designation, closing a decades-old regulatory loophole that allowed manufacturers to self-certify ingredient safety without federal oversight.
Scholar Rock announced it will remove Novo Nordisk's (formerly Catalent's) Indiana manufacturing facility from its FDA biologics license application for a treatment targeting a rare neuromuscular disease. The regulatory filing adjustment comes as the company seeks approval for its muscle weakness therapy.
The FDA has approved Takeda's Orzeyful (orexin agonist) for treating narcolepsy type 1 in adults, marking the first approval in a new class of sleep medicines that addresses the full range of narcolepsy symptoms. The approval is expected to reshape the treatment paradigm and launch a closely watched commercial drug race.
Becton Dickinson is recalling certain lots of intraosseous vascular access system needle sets following reports of four deaths and multiple injuries. The FDA issued an early alert warning that needle components may lock during insertion, potentially delaying critical care.
DeepHealth, a RadNet subsidiary, received FDA 510(k) clearance for an AI platform that automates breast ultrasound lesion detection, characterization according to ACR BI-RADS standards, and report generation. The technology aims to address the time-intensive, operator-dependent nature of ultrasound breast cancer screening.
The FDA has approved Novartis' radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for use in combination with hormone therapy for patients with PSMA-positive metastatic prostate cancer who are still hormone-sensitive, nearly doubling the eligible patient population from its previous indication for hormone-resistant cases.
An FDA advisory panel voted against approving Capricor's deramiocel, a cell therapy for Duchenne-related cardiomyopathy, determining the company had not sufficiently proven the treatment's benefits. The contentious decision could have broader implications for other rare disease drug developers.
A multistate salmonella outbreak has infected 98 people and hospitalized 26 across 17 states since November, prompting Midwest Poultry Services to recall nearly 1.6 million dozen eggs sold at major retailers including Kroger and Brookshire's. Federal health officials say the recalled eggs don't account for all illnesses in the ongoing investigation.
The U.S. Food and Drug Administration has approved LYTENAVA (bevacizumab-vikg) for treating neovascular age-related macular degeneration (wet AMD), marking the first FDA-approved ophthalmic formulation of bevacizumab after 20 years of off-label use. The approval comes on Outlook Therapeutics' fourth regulatory attempt, though the company faces cash constraints as it enters commercialization.
A U.S. federal judge ruled that Biden-era FDA restrictions on prescribing the abortion drug mifepristone are unlawful and unjustified, ordering the Trump Administration to reconsider existing regulations. The decision comes as over 400 state lawmakers from all 50 states have signed an amicus brief demanding protection for telehealth abortion care access.
Outside advisers to the U.S. Food and Drug Administration narrowly voted to recommend broader access to several unapproved peptides popular in wellness circles, backing a push by HHS Secretary Robert F. Kennedy Jr. despite objections from FDA career scientists about limited safety data and potential conflicts of interest among panelists.
The U.S. Food and Drug Administration approved a nonprescription fixed-dose combination pill containing acetaminophen (650 mg) and naproxen sodium (220 mg), marketed as Tylenol with Naproxen by Kenvue. The medication provides up to 12 hours of pain relief for patients aged 12 and older.
The U.S. Food and Drug Administration announced Dexcom as the inaugural manufacturer selected for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, which coordinates with CMS's outcomes-based ACCESS model to align device market entry and reimbursement processes.
The FDA selected seven companies including Eli Lilly and Regeneron for a pilot program designed to speed up reviews of new domestic pharmaceutical manufacturing facilities, aiming to strengthen U.S. drug supply chains.
The U.S. Food and Drug Administration has rejected a proposal to reduce regulatory oversight of AI-powered medical devices, highlighting growing policy tension between promoting innovation and ensuring patient safety as AI adoption accelerates in healthcare.
The FDA has implemented a new policy that will permit some flavored vaping products to stay on the market without agency authorization, raising concerns among public health experts after the agency previously warned about harmful kratom-derived products.
Six former FDA officials shared their reasons for leaving the agency following significant staffing cuts and policy changes under the Trump administration. The departures come amid concerns about the agency's capacity to respond to public health threats like the ongoing hantavirus outbreak.
The Centers for Medicare & Medicaid Services and FDA announced a new pathway to streamline Medicare coverage for breakthrough medical devices, cutting red tape and providing predictability for device manufacturers and faster patient access to life-changing technologies.
