13 March 2024 - First known breakthrough therapy designation granted by the FDA for an adjunctive psychedelic based therapy for the ...
11 March 2024 - Submission is supported by data from the Phase 3 QUASAR program, which showed a significantly greater percentage ...
11 March 2024 - Submission is based on 2 year confirmatory results from the Phase 3 PROTECT study in which Filspari ...
11 March 2024 - Viatris has been informed that Mapi Pharma has received a complete response letter regarding the new drug ...
11 March 2024 - Approval extends treatment of Praluent to children aged 8 and older with heterozygous familial hypercholesterolaemia. ...
10 March 2024 - The BLA for CT-P39 was based on totality of evidence including results from Phase III data ...
7 March 2024 - Fresenius Kabi announced today that the US FDA has approved Tyenne (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra ...
8 March 2024 - Today, the US FDA approved a new indication for use for Wegovy (semaglutide) injection to reduce the ...
7 March 2024 - Mind Medicine today announced that FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program for ...
7 March 2024 - Today, the FDA granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) with obinutuzumab for relapsed or refractory ...
7 March 2024 - On 6 March 2024, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) in combination with cisplatin and gemcitabine ...
6 March 2024 - Trellis Bioscience is thrilled to announce that its lead antibody candidate, TRL1068, has been granted fast ...
6 March 2024 - Today, the FDA approved inotuzumab ozogamicin (Besponsa, Pfizer) for paediatric patients 1 year and older with ...
6 March 2024 - Vanda Pharmaceuticals today announced that on 4 March 2024, it received a complete response letter from ...
5 March 2024 - PDUFA set to 21 October 2024. ...