Pins matching tag:Approval

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.

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.

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.

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 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 23 June 2026 the European Commission approved Sanofi's Cenrifki (tolebrutinib) for secondary progressive multiple sclerosis without relapses, the first EU medicine aimed at disability progression in that group.

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.