Food and Drug Administration
government organization in Nonthaburi, Thailand
Activity
FDA fast-tracks approval for three psychedelic drugs targeting depression and PTSD
The FDA has approved an accelerated review for three psychedelic drugs in development for depression and PTSD. This strategic move could speed up the availability of new mental health treatments and signifies rising acceptance of psychedelics in medicine.
Trump Signs Executive Order to Fast-Track Psychedelic Drug Research and Access
President Donald Trump recently signed an executive order to accelerate the approval process for psychedelic therapies, including psilocybin and ibogaine. The move is expected to boost research and commercialization, impacting mental health treatment options.
E. coli Outbreak Sickens 7 Across 3 States Linked to Raw Farm Cheddar Cheese
Seven people across three states fell ill from an E. coli outbreak linked to Raw Farm's raw cheddar cheese. The FDA and CDC are investigating while urging caution amid refusal of product recall by the cheese producer.
FDA approves 7.2 mg Wegovy boosting weight loss 21%; Indian generics cut prices to $14/month
The FDA approved a triple-strength 7.2 mg dose of Wegovy, enabling patients to lose 21% body weight on average. Simultaneously, Indian companies launched significantly cheaper generic versions of semaglutide drugs, broadening global access and upping market competition.
Trump enforces 100% tariffs on imported patented drugs, seeks U.S. manufacturing boost
The Trump administration has enacted a 100% tariff on certain imported patented drugs to boost U.S. pharmaceutical manufacturing and reduce foreign dependency. The policy includes incentives for domestic production but may have significant global trade implications, particularly for countries like India.
Eli Lilly’s FDA-Approved Obesity Drug Foundayo Challenges Wegovy's Market Lead
Eli Lilly’s FDA-approved oral obesity drug Foundayo offers a convenient alternative to Wegovy, intensifying competition in the weight-loss medication market and expanding patient options.
FDA recalls nearly 90,000 children's ibuprofen bottles over foreign matter with potential health risks
Nearly 90,000 bottles of children's ibuprofen from Strides Pharma were recalled due to foreign substances like black particles and gel-like masses. The FDA warns of possible temporary health effects, urging consumers to avoid use and consult doctors if needed.
FDA Crackdown on Telehealth and GLP-1 Drug Marketing Sparks Industry Shift
The FDA is cracking down on telehealth marketing related to GLP-1 drugs, focusing on unapproved weight loss medications. This industry action may disrupt prescribing practices and affect patient access. The crackdown signals increased regulatory scrutiny in the telehealth sector.
Hims & Hers and Novo Nordisk End GLP-1 Dispute Amid Rumors of Collaboration
Hims & Hers resolves its dispute with Novo Nordisk over Wegovy, coinciding with legal scrutiny over its Semaglutide claims. The company's stock surges amid rumors of a new collaboration with Novo Nordisk, signaling a potential strategic move in the market.
FDA Reverses Decision on Rare Blood Cancer Drug, Cigna Expands with CarepathRx Acquisition
FDA reverses its initial approval of a rare blood cancer drug, raising concerns about regulatory stability. Separately, Cigna acquires CarepathRx to deepen its presence in hospital pharmacy services, marking a significant expansion.
FDA Pushes for Over-the-Counter Access Amid Industry Resistance to GLP-1 Drugs
The FDA is pushing for over-the-counter access to medications like GLP-1 drugs, sparking debate over safety, profits, and public health. Industry resistance and regulatory challenges complicate this push.