Drug approval – Discover Pharma

Welcome to Discover Pharma! Today is : April 20, 2026

Drug approval

Cardiovascular diseases,Clinical Trials,Drug approval,Rare Diseases
Chiesi gains CHMP backing for lomitapide in children with rare cholesterol disorder
Chiesi Global Rare Diseases has received a positive CHMP opinion [...]

March 31, 2026
Biologics & Biosimilars,Biomanufacturing,Biotech,Clinical Development,Clinical Trials,Drug approval,Drug Development,FDA,Rare Diseases,Research & Development
Hansa Biopharma’s BLA for imlifidase accepted by FDA
Hansa Biopharma’s Biologics License Application (BLA) for imlifidase has been [...]

February 19, 2026
Chronic diseases,Drug approval,Drug Delivery & Formulation,Immunology,Pharmaceuticals and therapeutics,Respiratory
Exdensur approved by European Commission for severe asthma and chronic rhinosinusitis with nasal polyps
GSK announced that the European Commission has approved Exdensur (depemokimab) [...]

February 18, 2026
Biologics & Biosimilars,Clinical Development,Drug approval,FDA,Funding,Pharmaceuticals and therapeutics,Rare Diseases,Regulatory Affairs
Hansa Biopharma reports 135% Q4 revenue growth and BLA submission for imlifidase
Hansa Biopharma has reported a 135% increase in fourth-quarter revenue [...]

February 13, 2026
Dermatology,Drug approval,Market Access & Commercialization,Regulatory Affairs
Almirall secures China approval for Seysara acne treatment
Almirall has received regulatory approval in China for its oral [...]

February 3, 2026
Clinical Development,Drug approval,Genetic Diseases,Rare Diseases,Regulatory Affairs
Pegunigalsidase alfa every four weeks dosing backed by CHMP for adult Fabry patients
The European Medicines Agency’s Committee for Medicinal Product for Human [...]

February 2, 2026
Cardiovascular diseases,Drug approval,Market Access & Commercialization,Pharmaceuticals and therapeutics
Milestone launches CARDAMYST nasal spray for PSVT in the United States
Milestone Pharmaceuticals has announced the commercial availability of CARDAMYST (etripamil) [...]

January 26, 2026
Drug approval,Immunology,Pharmaceuticals and therapeutics,Rare Diseases,Regulatory Affairs,RNA Therapeutics
Donidalorsen granted EU approval for hereditary angioedema prevention
Donidalorsen has received European Union marketing authorisation for the routine [...]

January 23, 2026
Clinical Development,Clinical Trials,Drug approval,Oncology,Pharmaceuticals and therapeutics,Rare Diseases,Regulatory Affairs
FDA accepts Merck NDA for pimicotinib in tenosynovial giant cell tumor
Merck has announced that the US Food and Drug Administration [...]

January 13, 2026
Drug approval,Oncology,Precision medicine,Regulatory Affairs,Respiratory
NICE recommends amivantamab and lazertinib as first-line option for EGFR-mutated lung cancer
The National Institute for Health and Care Excellence has [...]

December 19, 2025