6 September 2024 - Axogen announced that it has completed the rolling submission process for its biologics license application to the ...
3 September 2024 - FDA PDUFA goal date of 17 June 2025. ...
6 September 2024 - Sun Pharma and Moebius Medical announced that the US FDA has granted fast track designation to ...
3 September 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Nymalize (nimodipine) oral solution in a 30 ...
3 September 2024 - The US Government's first ever negotiated prices for prescription drugs are still on average more than ...
5 September 2024 - Conversion to full approval based on results from the PROTECT study, where Filspari delivered superior long-term kidney ...
5 September 2024 - Current evidence suggests that tafamidis and acoramidis provide a net health benefit when compared to no ...
5 September 2024 - On 2 September 2024, Simcere Pharmaceuticals announced that Sanbexin sublingual tablets (edaravone and dexborneol sublingual tablets), an ...
5 September 2024 - Perspective Therapeutics today announced that the US FDA granted fast track designation for the development of ...
3 September 2024 - Foundation Medicine’s tissue and liquid biopsy tests can now be used to identify more patients who could ...
4 September 2024 - Axsome Therapeutics today announced that the US FDA has acknowledged the resubmission of the Company’s new drug ...
4 September 2024 - The use of surrogate markers to support drug approvals without requiring postmarketing studies can “hinder accurate ...
4 September 2024 - Synthekine today announced that the US FDA has granted fast track designation to SYNCAR-001 + STK-009, ...
4 September 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its PD-1/IL-2α bispecific antibody ...
3 September 2024 - Unicycive Therapeutics today announced that the Company has submitted a new drug application to the US FDA ...