The International Society for Cell and Gene Therapy (ISCT) has announced the publication in Nature Medicine of a commentary addressing a statement from the US F 12 January 2024
A generics drugmaker has had its Abbreviated New Drug Application for the radiopharmaceutical 177Lu-PNT2003 accepted by the US Food and Drug Administration. 12 January 2024
Japanese drugmaker Astellas has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Lic 9 January 2024
The US Food and Drug Administration has authorized a drug importation program in Florida, as the state seeks to benefit from lower cost medicines across the bor 8 January 2024
Californian biotech Amgen has announced that the US Food and Drug Administration has rejected its bid for full approval of Lumakras (sotorasib). 28 December 2023
Swedish drugmaker Calliditas Therapeutics has received full US Food and Drug Administration approval for Tarpeyo (budesonide), upgrading a previous nod under th 21 December 2023
For a second time, the US Food and Drug Administration has rejected a submission from Merck & Co (NYSE: MRK) for approval to market a chronic cough medication. 21 December 2023
A commercial stage biopharmaceutical R&D company, focused on the development of products that address the medical challenges in the therapeutic area of anti-infectives.