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Feb 17, 2026
Moderna received European Commission marketing authorization for its COVID-19 vaccine mNEXSPIKE for individuals aged 12 and older. The FDA also reversed its decision and agreed to review the company's seasonal flu vaccine application.
Feb 17, 2026
The European Commission approved MYQORZO (aficamten) for treating symptomatic obstructive hypertrophic cardiomyopathy in adults, completing global regulatory approvals following FDA and China NMPA clearances. First European launch planned in Germany in Q2 2026.
Feb 17, 2026
The European Commission has approved GSK's Exdensur (depemokimab) as the first ultra-long-acting biologic for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps, offering twice-yearly dosing based on positive phase 3 trial results.
Feb 16, 2026
ExCellThera's cell therapy Zemcelpro (dorocubicel) has been granted NUB Status 1 in Germany, allowing hospitals to apply for temporary supplementary reimbursement. 220 German hospitals have expressed interest in offering the therapy in 2026.
Feb 16, 2026
New data from LIBERTY studies show subcutaneous infliximab effectively restored and maintained disease control in Crohn's disease and ulcerative colitis patients after drug holiday of 16 weeks or more, with sustained efficacy through Week 102.
Feb 14, 2026
The European Commission granted conditional marketing authorization for ANKTIVA plus BCG to treat BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, marking the first approved immunotherapy for this indication in Europe.
Feb 14, 2026
The European Medicines Agency recommended conditional marketing authorization for Anktiva in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer in December 2025.
Sep 11, 2025
The FDA issued a Complete Response Letter for Corcept's relacorilant as a treatment for hypertension secondary to hypercortisolism, requesting additional evidence of effectiveness despite acknowledging positive trial results.
Dec 11, 2025
Amgen received FDA and European Commission approval for Uplizna to treat generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, offering twice-yearly maintenance dosing after initial loading doses.
Feb 12, 2026
The European Commission has granted marketing authorization for Moderna's mNEXSPIKE (mRNA-1283) COVID-19 vaccine for individuals aged 12 years and older across all 27 EU member states plus Iceland, Liechtenstein and Norway.
Feb 13, 2026
The European Commission has granted marketing authorization for Gotenfia, a golimumab biosimilar to Simponi, developed by Bio-Thera and to be commercialized by STADA across the EU, EEA, UK, Switzerland and selected other countries.
Feb 13, 2026
The European Commission has approved Gotenfia (golimumab), a biosimilar to Simponi developed by Bio-Thera and marketed by STADA, for chronic inflammatory autoimmune diseases across the EU and EEA.
Feb 13, 2026
PTC Therapeutics withdrew its resubmitted new drug application for Translarna in Duchenne muscular dystrophy after the FDA indicated the data was unlikely to meet the threshold for substantial evidence of effectiveness, marking the third unsuccessful US approval attempt.
Feb 13, 2026
PTC Therapeutics has withdrawn its New Drug Application resubmission for ataluren (Translarna) for nonsense mutation Duchenne muscular dystrophy after the FDA indicated the submission lacked substantial evidence of effectiveness.
