For more than a decade, external and historical controls have occupied a complicated middle ground in US Food and Drug ...

BioMarin Pharmaceutical today announced that the US Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application (sBLA) for Palyvziq (pegvaliase-pqpz) to ...

Latin America is making steady progress in harmonizing its regulatory frameworks and strengthening participation in ...

Swiss dermatology focused biopharma Galderma today announced new data from the OLYMPIA open-label extension study ...

US biotech Earendil Labs has entered a strategic collaboration with Hong Kong-listed WuXi XDC (HKEX: 2268), securing an ...

Chinese drugmaker Jiuyuan Genetic Biopharmaceutical (HKEX: 2566) has applied for approval to market its biosimilar version of ...

German family-owned pharma major Boehringer Ingelheim and UK clinical stage biotech Sitryx Therapeutics announced that ...

Germany’s Bayer has announced encouraging results from the ongoing global Phase I first-in-human dose-escalation PAnTHa study of 225Ac-PSMA-Trillium, a targeted alpha therapy in advanced metastatic ca ...

US pharm major Eli Lilly today announced detailed results from ACHIEVE-3, the first head-to-head Phase III trial evaluating ...

Switzerland’s Santhera Pharmaceuticals has announced that the Spanish Interministerial Commission on Prices of Medicines has proposed to include Agamree (vamorolone) in the pharmaceutical coverage of ...

Swiss pharma Novartis (NOVN: VX) is to build a 46,000-square-foot radioligand therapy manufacturing facility in Texas, its ...

The US Food and Drug Administration (FDA) has granted accelerated approval to Hernexeos (zongertinib), from German family ...