Drug Approval | August 29, 2025
Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing
The submission is supported by results from the Phase 3b APEX study
For patients with resectable early-stage gastric and gastroesophageal junction cancers
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
Capricor’s BLA for Deramiocel received Priority Review in March 2025
Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
Approval is based on positive data from the Phase 3 ECHELON-3 trial
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