19 January 2023 - FDA sets PDUFA date of 22 May 2023. ...
19 January 2023 - Synlogic today announced that SYNB1934 was granted rare paediatric disease designation by the US FDA for the ...
18 January 2023 - GC Pharma said on Wednesday that its San Filippo Syndrome type A treatment, jointly being developed ...
18 January 2023 - Purdue Pharma announced that FDA has accepted and granted priority review to the company’s abbreviated new ...
17 January 2023 - Orphagen Pharmaceuticals today announced that the US FDA has granted rare paediatric disease designation for OR-449 ...
5 January 2023 - Results from the pivotal Phase 1/2 NP30179 study showed glofitamab induced durable response rates in people with ...
6 January 2023 - If approved, the vaccine would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants ...
6 January 2023 - bluebird bio today announced that it has entered into a definitive agreement to sell its second ...
5 January 2023 - Infex Therapeutics is pleased to announce that the US FDA has granted qualified infectious disease product ...
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...
5 January 2023 - AUM Biosciences announced today that the US FDA has granted a rare paediatric disease designation for its ...
26 December 2022 - Low cost, over the counter naloxone nasal spray advances to FDA review. Approval would increase access ...
15 December 2022 - Alexis Bio today announced that realSKIN is the first live cell xenotransplant product to be designated ...
7 December 2022 - If approved, RSVpreF would help address the substantial burden of RSV disease in individuals 60 years ...
30 November 2022 - Sulbactam-durlobactam is a targeted antibiotic that was specifically designed to treat serious infections caused by Acinetobacter baumannii, ...