BeiGene's TEVIMBRA expands for cancer treatment, and BRUKINSA sales soar 107%. See why BGNE stock presents upside potential ...

It also means that most regulatory watchers may not be looking at the appropriate endpoint for calculating and comparing relative cycle times. In most cases, the EC agrees with the CHMP's ...

The treatment for ATTR in certain adults with polyneuropathy had just been recommended for approval across the European Union and had gained regulatory approval in the United States at the end of 2023 ...

NDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November ...

Generated $196.8 million in 3Q 2024 revenues, including $176.6 million in U.S. net product salesGrew SYFOVRE® (pegcetacoplan injection) demand by ...

Madrigal Pharmaceuticals' Rezdiffra has favorable initial market adoption and FDA approval. Read why I maintain my buy rating ...

The first bispecific antibody to win regulatory approval is about to make a comeback 10 ... ascites from the EMA’s Committee for Medicinal Products for Human Use (CHMP,) at its monthly meeting Oct. 14 ...

Astellas to withdraw European marketing authorization application for avacincaptad pegol to treat GA secondary to AMD: Tokyo Tuesday, October 29, 2024, 13:00 Hrs [IST] Astellas Ph ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the third quarter of 2024 and provided a business update. "Regeneron had a strong third quarter marked by 11% ...

Merck worried investors late last year when it withdrew a European filing for Keytruda in this indication based on phase 2 data from KEYNOTE-021, because the CHMP regulatory committee had not been ...

This week, Roche RHHBY announced its third-quarter and nine-month results. Sanofi SNY confirmed that it is holding exclusive ...