Drug Approval | November 13, 2024
EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
Results from the open-label extension study of PHOTON demonstrate patients with diabetic macular edema (DME) randomized to Eylea 8 mg maintained visual and anatomic improvements at the end of three years
MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA
Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population
PEKK is a high-performance polymer family used in aerospace and other demanding markets
Renews GMP certifications for India and Malaysia sites
DSP-5336, an Investigational Menin and Mixed-lineage Leukemia Inhibitor, is Being Evaluated in Patients with Relapsed or Refractory Acute Leukemia
Abbott's first-of-its-kind i2i technology enables synchronized communication between two leadless pacemakers
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