26 February 2024 - Submission supported by positive results of a Phase 3 study showing immune response and tolerability in adults ...
26 February 2024 - FDA grants priority review with target action date of 28 June 2024. ...
23 February 2024 - Priority review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be ...
22 February 2024 - Curium announced today that the marketing authorisation application for Pylclari (piflufolastat (18F)) submitted by exclusive Swiss ...
21 February 2024 - Prescription Drug User Fee Act date is 21 June 2024. ...
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 - Prescription Drug User Fee Act target action date is 21 June 2024. ...
20 February 2024 - Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial. ...
20 February 2024 - BMS today announced that the US FDA has accepted for priority review the supplemental new drug ...
19 February 2024 - Starpharma today announces that it has completed the formal dispute resolution process with the US FDA in ...
19 February 2024 - Application based on results from the TROPION-Lung01 Phase 3 trial. ...
15 February 2024 - Priority review designation is based on results from the Phase 3 EV-302 trial, which found enfortumab vedotin ...
16 February 2024 - Priority review granted, with a review goal date of 21 June 2024. ...
13 February 2024 - FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act ...