FDA
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FDA Approves Otarmeni, First Dual-AAV Gene Therapy for Severe Hearing Loss
The FDA has approved Otarmeni, a pioneering gene therapy for severe hearing loss caused by OTOF gene mutations. This landmark approval could transform treatment options and improve quality of life for affected individuals.
FDA Approves Regeneron's First Gene Therapy to Restore Hearing in Deaf Children
Regeneron has secured FDA approval for a pioneering gene therapy that restores hearing in children with a specific genetic deafness. This breakthrough advances medical science and could change the landscape of treatment for genetic hearing impairments.
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.
Hims & Hers Stock Surges 14% as FDA Plans Review of Peptide Compounding Eligibility
Hims & Hers stock rose 14% after the FDA scheduled a review of peptide compounding eligibility, a move that could open new market prospects. The outcome of the review in July will impact the company's growth trajectory and competitive positioning.
FDA requests further safety data from Eli Lilly on Foundayo's liver injury risks
The FDA has requested additional safety information from Eli Lilly regarding liver injury concerns linked to Foundayo. This step indicates heightened regulatory scrutiny even after the drug's recent approval.
Surge in Online Searches and Policy Changes Highlight Growing GLP-1 Weight-Loss Drug Concerns
Following a Super Bowl commercial, online searches for GLP-1 weight-loss drugs have skyrocketed, raising safety concerns over unverified sales. Simultaneously, some US states are cutting Medicaid coverage, complicating access for low-income users.
FDA Considers Loosening Restrictions on Peptides Favored by RFK Jr. Supporters
The FDA is reviewing a proposal to ease restrictions on peptides popular with RFK Jr. supporters, potentially expanding legal access. This raises concerns about safety and regulation as the use of these controversial drugs grows in alternative health circles. The decision will impact the regulation of supplements and public safety measures.
FDA Rejects Replimune's Cancer Therapy RP1 Again, Citing Manufacturing Concerns
Replimune's stock dropped 64% after the FDA rejected its cancer therapy RP1 for a second time due to manufacturing issues. The setback could delay the therapy's approval and impact the company's development pipeline.
Novo Nordisk to Cut U.S. Prices of Key Obesity Drugs, Stocks Dip as Competitors Gain Edge
Novo Nordisk is planning to cut the U.S. list prices of Wegovy by 50% starting in 2027. Meanwhile, Eli Lilly has gained an advantage in the obesity drug market with its recent product launch, while Novo's new drug trials lag behind.
Ghana FDA Orders Seafood Ban from Tema Shipyard Amid Fish Kill Alarm
The FDA in Ghana has issued a ban on consuming fish from the Tema Shipyard area following the discovery of dead fish, initially reported on April 6. This development underscores the urgency and seriousness of the ongoing investigations into environmental and health impacts.
FDA Approves Eli Lilly's Foundayo Oral GLP-1 for Weight Management
The FDA has approved Eli Lilly's new oral GLP-1 weight-loss medication, Foundayo, for adults with obesity or overweight. This approval introduces a convenient pill option that could significantly shift weight management treatments and market dynamics.
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.
Apple’s Studio Display XDR Receives FDA Clearance for Medical Imaging
Apple's Studio Display XDR has gained FDA clearance for its new medical imaging calibration feature, enabling diagnostic use. This advancement may transform medical diagnostics by integrating high-quality consumer displays into clinical workflows.
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.
California Raw Milk Dairy Linked to E. coli Outbreak Sickening Nine Including Children
Nine people across three states have become ill from E. coli linked to raw cheese from California's Raw Farm. The outbreak has prompted calls for a recall and renewed scrutiny of raw dairy products.
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 Approves Denali's Hunter Syndrome Drug, Signaling Shift in Rare Disease Policy
The FDA has granted accelerated approval to Denali Therapeutics' drug for Hunter syndrome, marking a significant step forward. This approval occurs amid tighter regulatory scrutiny on rare disease treatments, signaling a potential shift in policy and industry practices.
FDA Warns Patrick Soon-Shiong Over Misleading Cancer Drug Claims
The FDA issued a warning to Dr. Patrick Soon-Shiong for making misleading claims about a cancer drug from his company. This raises concerns about drug marketing accuracy and potential regulatory actions ahead.
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.
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.