EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema

LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment

USFDA accepts biologics license application for GC Biopharma's GC5107B

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities

Synexa Joins CEPI in advancing global epidemic preparedness and response

Synexa joins CEPI’s esteemed Central Lab Network to improve global epidemic preparedness

Concept Medical gets 4th IDE approval from USFDA

For the treatment of Superficial Femoral Artery

IOL Chemicals and Pharmaceuticals receives CEP for Paracetamol to export in European market

The certification issued by the EDQM verifies the compliance of pharmaceutical substances

SÜDPACK’s PharmaGuard blister concept to add to sustainability

SÜDPACK is setting standards in terms of both performance and sustainability

FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric

Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression

Cepheid launches its first manufacturing unit in India

The facility has been set up to manufacture tuberculosis testing cartridges

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma