23 February 2024 - Simlandi is the first citrate free, high concentration biosimilar to be designated interchangeable to Humira in the ...
23 February 2024 - No clinical safety or efficacy issues identified. ...
23 February 2024 - Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was ...
23 February 2024 - Priority review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be ...
21 February 2024 - Prescription Drug User Fee Act date is 21 June 2024. ...
20 February 2024 - Avidity Biosciences today announced that the US FDA has granted rare paediatric disease designation to AOC 1044, ...
22 February 2024 - Artiva Biotherapeutics announced today that the US FDA has granted fast track designation to Artiva’s lead ...
21 February 2024 - United Therapeutics said on Wednesday it had filed a case with the US FDA, alleging that ...
20 February 2024 - Biweekly dosing with Tecvayli, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility. ...
21 February 2024 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...
20 February 2024 - Omnix Medical today announced that the Company has received fast track designation for its novel anti-infective ...
20 February 2024 - Company expects multiple readouts from its Phase 1/2a clinical trial in 2024. ...
20 February 2024 - PepGen today announced that the US FDA has granted fast track designation to PGN-EDODM1, an investigational candidate ...
20 February 2024 - Disc Medicine today announced that the US FDA has granted fast track designation to DISC-0974 for the ...