Nasdaq

Heron Announces European Medicines Agency Validation of Marketing Authorisation Application for HTX-011 for Postoperative Pain Management

SAN DIEGO, April 1, 2019 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class ...
RAPS

EMA Releases Draft Guideline on Process Validation

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Business Wire

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 ...
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 ...
Business Wire

Validation, Verification & Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...
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 ...