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 ...

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

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

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 ...

Apellis Pharmaceuticals APLS announced that the Committee for Medicinal Products for Human Use (CHMP) of the European ...

The conventional regulatory framework applied for the development ... of the Committee for Medicinal Products for Human Use (CHMP) to the developers of biosimilar products has important ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has consistently ... Europe is compounded by delays in the US regulatory process, where the FDA has yet ...

Other ongoing measures that aim to ensure the sustainability of the EU regulatory network are: Reinforcing best practices for requests for clock-stop extensions: In April 2024, EMA’s human medicines ...

The CHMP recommendation dated September 19 ... as the data support and as regulatory agencies recommend. The COVID-19 vaccines (COMIRNATY ®) by Pfizer and BioNTech are based on BioNTech ...

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