SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally
The receipt of EIR reaffirms the company's commitment to maintaining global quality standards
The receipt of EIR reaffirms the company's commitment to maintaining global quality standards
Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments
Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,
Capricor’s BLA for Deramiocel received Priority Review in March 2025
Celecoxib is a nonsteroidal anti-inflammatory drug
Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product
Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need
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