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May 22, 2026
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
May 14, 2026
The European Commission expanded Hympavzi approval to patients 12 and older with hemophilia A or B with inhibitors. Phase 3 data showed a 93% reduction in mean treated annualized bleeding rate versus on-demand therapy.
May 07, 2026
Merck's Enflonsia (clesrovimab) receives EU approval for RSV prevention in infants. Separately, researchers identify a monoclonal antibody cocktail from pediatricians' immune cells that shows potent protection against RSV and hMPV in animal studies.
May 06, 2026
The EU Critical Medicines Act enters trilogue negotiations as drug shortages persist. The Parliament proposes broader powers for a new coordination group, binding stockpiling, and expanded MEAT procurement criteria. EMA recorded 136 critical shortages from 2022-2024.
May 01, 2026
Aurobindo Pharma's subsidiaries secured Health Canada approval for bevacizumab biosimilar Bevqolva, an EU distribution deal with STADA for two EMA-approved biosimilars, and US FDA approval for ADQUEY ointment for atopic dermatitis.
Apr 21, 2026
Regeneron said the Phase 3 NIMBLE trial of cemdisiran in generalized myasthenia gravis met primary and key secondary endpoints at week 24. The company said a U.S. regulatory application has been submitted and EU filings are planned for 2026.
Apr 18, 2026
The FDA approved acalabrutinib plus venetoclax for previously untreated CLL/SLL based on phase 3 AMPLIFY data. The fixed 14-month regimen improved progression-free survival versus chemotherapy.
Mar 31, 2026
The European Commission has approved KYGEVVI (doxecitine and doxribtimine) as the first treatment for thymidine kinase 2 deficiency (TK2d), an ultra-rare mitochondrial disease. Clinical studies showed the drug reduces death risk by 95% and helps 84% of patients regain motor functions. The approval covers pediatric and adult patients with symptom onset before age 12.
Mar 26, 2026
The European Union has approved a higher 7.2 mg maintenance dose for Wegovy (semaglutide) for chronic weight management. Clinical trial data shows mean weight loss of 20-21% with the 7.2 mg dose compared to 17-18% with the standard 2.4 mg dose. The approval provides clinicians with an on-label option for patients with inadequate response to standard dosing.
Mar 24, 2026
Egetis Therapeutics completed its rolling New Drug Application for Emcitate® (tiratricol) for MCT8 deficiency in the USA on January 29, 2026. The drug received European Commission approval in February 2025 and launched in Germany in May 2025. The company also provided updates on Japanese regulatory progress and the status of its Aladote® candidate for paracetamol overdose.
Mar 12, 2026
BioVersys has dosed the first patient in a Phase 2b trial evaluating alpibectir-ethionamide (AlpE) in combination with first-line TB drugs, following promising Phase 2a results published in the New England Journal of Medicine.
Feb 18, 2026
Novartis reported positive Phase III RemIND trial results showing remibrutinib achieved complete response in three types of chronic inducible urticaria. The company has submitted a supplemental New Drug Application to the FDA for symptomatic dermographism.
Feb 20, 2026
The FDA has accepted for Priority Review Regeneron's biologics license application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target action date of August 2026.
Feb 19, 2026
The UK and US announced a pharmaceuticals agreement featuring zero tariffs and a 25% increase in UK spending on innovative medicines. Major pharma M&A deals and regulatory reforms are reshaping the industry in early 2026.
Feb 19, 2026
The FDA has accepted for Priority Review the Biologics License Application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target decision date of August 2026. The application is supported by Phase 3 OPTIMA trial data showing significant reductions in heterotopic bone lesions.
