News | July 15, 2025
Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
Capricor’s BLA for Deramiocel received Priority Review in March 2025
Capricor’s BLA for Deramiocel received Priority Review in March 2025
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
Xtandi is approved in over 80 countries, including the U.S., EU, and Japan
Additional data will be presented on a once-weekly oral combination of islatravir and ulonivirine (ISL/ULO) for HIV-1 treatment
atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design.
New findings reveal bemarituzumab plus chemotherapy significantly improves survival in advanced gastric cancer, offering hope for targeted treatment options
mRNA-1010 demonstrated superior relative vaccine efficacy
The approval in China is supported by a robust local clinical development program confirming the drug’s safety, tolerability, and efficacy profile
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
BioNTech and Bristol Myers Squibb will jointly execute a broad clinical development program to evaluate and advance BNT327 across numerous solid tumor types
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