Related coverage linked through entity extraction aliases.
Feb 13, 2026
Praxis Precision Medicines is preparing to submit two New Drug Applications by mid-February 2026 for ulixacaltamide and relutrigine, both holding FDA Breakthrough Therapy Designation, targeting essential tremor and epilepsy markets.
Feb 13, 2026
The global genomics in cancer care market is projected to grow from $24.39 billion in 2025 to $108.69 billion by 2035, driven by rising cancer incidence, personalized medicine adoption, and next-generation sequencing advances.
Feb 13, 2026
Researchers find that AMD3100, an existing FDA-approved drug, can reverse T-cell exclusion in fibrolamellar carcinoma, potentially allowing immunotherapy to fight the rare and fatal liver cancer that primarily affects children and young adults.
Feb 13, 2026
Eli Lilly has accumulated $1.5 billion in pre-launch inventory of its experimental oral weight-loss drug orforglipron ahead of an expected FDA decision in April, up from $550 million last year.
Feb 13, 2026
The FDA announced plans to restrict non-FDA-approved compounded GLP-1 drugs mass-marketed as alternatives to approved weight loss medications, citing safety concerns and misleading advertising practices.
Feb 13, 2026
PTC Therapeutics withdrew its resubmitted new drug application for Translarna in Duchenne muscular dystrophy after the FDA indicated the data was unlikely to meet the threshold for substantial evidence of effectiveness, marking the third unsuccessful US approval attempt.
Feb 13, 2026
U.S. regulators have received more than 1,400 reports since 2021 involving AI-enabled surgical devices, including allegations of botched surgeries and misidentified body parts. The FDA has authorized over 1,300 AI-integrated medical devices.
Feb 13, 2026
Medtronic announced FDA clearance of the Stealth AXiS surgical system, a next-generation platform integrating planning, navigation, and robotics for spine surgery. The system features LiveAlign segmental tracking for real-time visualization.
Feb 13, 2026
PTC Therapeutics has withdrawn its New Drug Application resubmission for ataluren (Translarna) for nonsense mutation Duchenne muscular dystrophy after the FDA indicated the submission lacked substantial evidence of effectiveness.
Feb 10, 2026
The FDA reversed its refusal to review Moderna's mRNA flu vaccine application after the company amended its submission. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision expected by August 5, 2026.
Feb 10, 2026
Hims and Hers Health pulled its $49 compounded version of Novo Nordisk's Wegovy weight-loss pill after the FDA referred the company to the Department of Justice for potential legal violations.
Feb 13, 2026
The FDA has approved Optune Pax, a wearable device delivering tumor treating fields for locally advanced pancreatic cancer. The approval marks the first new treatment modality for this indication in nearly 30 years.
Feb 13, 2026
The FDA is set to make approval decisions on five drug applications in March 2026, including treatments for psoriatic arthritis, dry eye disease, hypothalamic obesity, cholestatic pruritus, and a rare genetic disorder.
Feb 13, 2026
The FDA approved Novocure's Optune Pax device for locally advanced pancreatic cancer treatment alongside chemotherapy, marking the first new treatment option in this indication since 1996. Phase III trial data showed statistically significant survival improvement.
Feb 13, 2026
The FDA mandated febrile seizure warnings for flu vaccines and rejected Moderna's mRNA flu vaccine application, with a political appointee overruling agency staff despite no safety concerns identified.
Dec 22, 2025
The FDA approved multiple denosumab biosimilars in late 2025 and issued REMS safety updates emphasizing severe hypocalcemia risk in patients with advanced chronic kidney disease, including reported hospitalizations and fatalities.
Feb 13, 2026
Emergent BioSolutions received FDA approval on Feb. 12, 2026, for 6-count and 24-count multipack configurations of over-the-counter NARCAN Nasal Spray, designed to meet the needs of partners distributing higher volumes of naloxone to community programs.
Feb 13, 2026
The FDA has approved labeling changes to six menopausal hormone therapy products, removing boxed warnings related to cardiovascular disease, breast cancer, and probable dementia that had been in place since 2003.
Feb 13, 2026
The FDA announced a new policy making one robust pivotal trial plus confirmatory evidence the default approval requirement, ending the two-trial standard. Separately, the agency finalized guidance on enhancing clinical trial participation to improve enrollment diversity.
Feb 13, 2026
Study finds FDA-approved drug AMD3100 can mobilize immune T cells to attack fibrolamellar carcinoma, a rare liver cancer affecting children and young adults that has resisted immunotherapy treatment.
