Drug Approval | February 25, 2023
Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%
The WHO has urged China to increase adoption of mRNA vaccines, given their high efficacy against variant strains.
NDM disorders are a group of rare, inherited neuromuscular disorders with an estimated prevalence of 1 case per 100,000 inhabitants in Spain, and are characterized by the inability to relax muscles following voluntary contraction (myotonia)
Partnership to leverage the Helix Laboratory Platform and QIAGEN's biopharma relationships, NGS capabilities, and global regulatory expertise
WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate COVID-19 patients at highest risk of hospital admission
EC grants conditional marketing authorization based on the EFFISAYIL trial
The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
Subscribe To Our Newsletter & Stay Updated
