Pins matching tag:FDA

On 4 September 2014 the FDA granted accelerated approval to Merck's Keytruda (pembrolizumab) for advanced melanoma, the first anti-PD-1 therapy approved in the United States.

On 23 August 2021 the FDA approved Comirnaty, the Pfizer-BioNTech COVID-19 vaccine, for people 16 and older, making it the first approved COVID-19 vaccine and the first approved mRNA therapy in the US.

A unanimous Supreme Court threw out anti-abortion doctors' challenge to the FDA's rules for the abortion pill mifepristone, holding they had no standing to sue, so mail and telehealth access stayed in place.

The FDA approved Evita Solutions' 200 mg mifepristone tablets as the second generic of the abortion pill, less than two weeks after HHS promised a safety review of the drug.

On 23 October 2025 the US FDA approved Blenrep with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma after at least two prior lines of therapy.

Abbott began a medical device correction for about 3 million FreeStyle Libre 3 and Libre 3 Plus sensors in the U.S. after internal testing found some give incorrect low glucose readings, an issue it linked to 736 severe adverse events and seven deaths worldwide. The FDA later made it a Class I recall.

On 16 December 2025 the US FDA approved Exdensur (depemokimab-ulaa) as add-on maintenance treatment for severe eosinophilic asthma in people aged 12 and over, dosed twice a year.

The FDA approved Abbott's Volt pulsed field ablation system, a balloon-in-basket catheter that maps, paces and ablates, to treat paroxysmal and persistent atrial fibrillation. The approval rested on the 392-patient VOLT-AF IDE study at 40 centers.

On 22 December 2025 the US FDA approved the once-daily Wegovy pill (oral semaglutide 25 mg), the first oral GLP-1 for weight management, which showed 16.6% mean weight loss in the OASIS 4 trial.

On 24 February 2026 the FDA approved Dupixent for adults and children aged 6 and older with allergic fungal rhinosinusitis who have had sino-nasal surgery, the first medicine approved for the condition and the drug's ninth US indication area.

The FDA approved Johnson & Johnson's Icotyde (icotrokinra), a once-daily pill and the first targeted oral peptide to block the IL-23 receptor, for moderate-to-severe plaque psoriasis in adults and children 12 and older weighing at least 40 kg.

On 19 March 2026 the US FDA approved Wegovy HD (semaglutide 7.2 mg, once weekly) for weight loss after the STEP UP trial showed 20.7% mean weight loss, the first GLP-1 approval under the FDA's priority voucher pilot.

On 2 April 2026 the FDA approved extending EYLEA HD dosing intervals to every 20 weeks, up to 5 months, for wet age-related macular degeneration and diabetic macular edema after a year of successful response.

On 23 April 2026 the FDA granted accelerated approval to Regeneron's Otarmeni (lunsotogene parvec-cwha, formerly DB-OTO), the first gene therapy for OTOF-related hearing loss, which Regeneron will supply free of charge in the US.

On 27 April 2026 the FDA's drug centre issued a proposal to withdraw approval of Amgen's Tavneos for ANCA-associated vasculitis, alleging lack of substantial evidence of effectiveness; Amgen disagrees and the drug stays on the market.

On 16 July 2026 the FDA approved Merck's Lipfendra (enlicitide), a once-daily 20 mg tablet and the first oral PCSK9 inhibitor, to lower LDL cholesterol in adults with hypercholesterolemia.

The FDA authorized Abbott's Libre Duo 10 Day, the first wearable to continuously track both glucose and ketones, which alerts people with diabetes aged 2 and older to rising ketones before diabetic ketoacidosis.

The FDA approved Abbott's TactiFlex Duo, a catheter that can deliver pulsed field ablation, radiofrequency energy or both in one procedure to treat complex atrial fibrillation. The approval rested on the FlexPulse IDE study.

An all-oral pairing that doubled median progression-free survival to 11.1 months from 5.5 in ESR1-mutated patients in the EMBER-3 trial. It is Inluriyo's second FDA approval in under a year.

The Senate HELP Committee questions Dr. Heidi Overton, President Trump's pick for FDA commissioner, at 10:30 a.m. ET in 430 Dirksen. If confirmed, the White House domestic policy aide would take over an agency that has lost more than 3,000 staff in the past year.

On 25 September 2026 the FDA approved AbbVie's Juvmo (tavapadon), a once-daily tablet and the first selective D1/D5 receptor agonist approved for adults with Parkinson's disease; AbbVie announced it on 28 September.

FDA's Vaccines and Related Biological Products Advisory Committee meets virtually, 9:00 a.m. to 1:00 p.m. ET, to recommend influenza strains for the 2027 Southern Hemisphere vaccines, with a public FDA webcast.

On 2 October 2026 Novo Nordisk said the FDA is extending its review of the denecimig BLA because of facility remediation, with no new decision date and a US launch aimed at the first half of 2027.

The FDA's PDUFA goal date for Inovio's INO-3107, a DNA medicine for adults with recurrent respiratory papillomatosis, is 30 October 2026 under the accelerated approval pathway.

The FDA extended its action date for Capricor's Duchenne muscular dystrophy cell therapy deramiocel from 22 August to 22 November 2026 after the company filed new HOPE-3 data and a narrower upper-limb indication.

Lilly plans to file its Biologics License Application for retatrutide, the triple-hormone obesity shot that cut weight by up to 28.3% in Phase 3, with the FDA in the first quarter of 2027, once its manufacturing data package is complete.