Business Insider

Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa

PITTSBURGH, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization ...
Seeking Alpha

Apellis and Sobi Announce EMA Validation of Indication Extension Application for Aspaveli® (pegcetacoplan) for C3G and Primary IC-MPGN

WALTHAM, Mass. and STOCKHOLM, Sweden, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (APLS) and Sobi ® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an ...
Nasdaq

Amylyx Pharmaceuticals Announces EMA Validation of Marketing Authorisation Application (MAA) for AMX0035 for the Treatment of ALS

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”), today announced that its Marketing Authorisation ...
News Medical

The Role of Process Validation in Ensuring Consistent Drug Quality

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
Benzinga.com

Raptor Pharmaceutical Corp. Announces EMA Validation of Marketing Authorization Application for RP103 for the Treatment of Nephropathic Cystinosis

Raptor Pharmaceutical Corp. RPTP, announced that the European Medicines Agency has determined that Raptor's Marketing Authorization Application (MAA) for its investigational drug candidate, RP103 for ...
GEN

AI Could Revolutionize Biopharma Process Validation

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...