Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studiesGranted Fast ...

The GMP inspection, conducted by European Medicines Agency (EMA) representatives from April 8th to April 12th, 2024, assessed ...

Marcel Imwinkelried, Chief Executive Officer Siegfried: “Aligned with Siegfried's strategy EVOLVE+, the new lab facility marks a key milestone in DINAMIQS' journey to becoming the leading CDMO in the ...

Krystal Biotech, Inc. (NASDAQ:KRYS) Q3 2024 Earnings Call Transcript November 4, 2024 Krystal Biotech, Inc. beats earnings expectations. Reported EPS is $0.909, expectations were $0.9. Operator: Thank ...

The addition of the ABL Rockville team and facility aligns more than three decades of development and manufacturing experience with additional virus modalities and GMP capacity for adeno-associated ...

Advanced therapy medicinal products (ATMPs) are pushing the boundaries of medicine, offering hope for previously untreatable ...

CHICAGO, IL / ACCESSWIRE / November 12, 2024 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a ...

CHICAGO, IL / ACCESSWIRE / November 12, 2024 / Cosmos Health Inc. ("Cosmos Health" or the "Company') (NASDAQ:COSM), a ...

As the European Union’s updated General Product Safety Regulation (GPSR) prepares to take effect on December 13, 2024, brands ...

Aurobindo Pharma's subsidiary, CuraTeQ Biologics, has received a GMP certificate from the European Medicines Agency for its ...