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Apr 28, 2026
Novartis received EU approval for Rhapsido (remibrutinib) as the first oral targeted treatment for chronic spontaneous urticaria. Phase 3 data also showed significant efficacy in chronic inducible urticaria, with filings underway for additional indications.
Apr 25, 2026
A U.K. focus-group study found support for sharing health data for AI is conditional on public benefit, safeguards and meaningful consent. The findings come as Europe tightens control over biomedical datasets under data-sovereignty policies.
Apr 24, 2026
Novartis received a positive CHMP opinion for Itvisma in spinal muscular atrophy patients aged 2 years and older. A European Commission decision is expected within about two months.
Apr 24, 2026
The European Commission has launched the Bioeconomy Investment Deployment Group and outlined a €350 million package for food and biotech innovation. The measures target financing gaps that have slowed scale-up from pilot projects to industrial deployment.
Apr 21, 2026
VYLOY (zolbetuximab-clzb) remains the only approved CLDN18.2-targeted therapy for first-line HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors. The pipeline is focused on next-generation antibodies, ADCs, CAR-T, NK-cell and bispecific approaches aiming to build on zolbetuximab benchmark data.
Apr 17, 2026
The European Commission approved Enflonsia for prevention of RSV lower respiratory tract disease in infants during their first RSV season. Merck also reported new Phase 3 SMART data showing generally consistent second-season safety in high-risk children under 2 years old.
Apr 06, 2026
Alterity is preparing for a mid-2026 end-of-Phase II FDA meeting for ATH434 in Multiple System Atrophy. Phase II data showed clinically meaningful and statistically significant effects, with safety comparable to placebo.
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 26, 2026
Precigen reported $3.4 million in first commercial sales of PAPZIMEOS in Q4 2025 following FDA approval for recurrent respiratory papillomatosis. The drug has received standard of care endorsement from physician experts and now covers approximately 90% of insured U.S. lives. The company has $100.4 million in cash and is pursuing European regulatory approval.
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 21, 2026
Deupirfenidone, a deuterated form of pirfenidone, is set to be tested in a phase 3 trial this year after successful phase 2b results. The FDA and European Commission have granted orphan drug designation to support its late-stage development.
Mar 15, 2026
Regulatory incentives for rare disease treatments, including market exclusivity and development subsidies, are spurring pharmaceutical innovation across the US, Europe, Japan, and Australia, with multiple companies advancing therapies for conditions affecting limited patient populations.
Mar 09, 2026
Regulatory authorities in the US and EU are proposing measures to reduce clinical data requirements and streamline approval processes for biosimilar drugs, aiming to accelerate access to lower-cost alternatives to biologic medications.
Mar 08, 2026
Novartis announced positive European regulatory opinion for remibrutinib in chronic spontaneous urticaria and reported the drug met its primary endpoint in a Phase 3 trial for chronic inducible urticaria.
Mar 07, 2026
Incyte received a Complete Response Letter from the FDA for Zynyz in lung cancer due to third-party manufacturing issues, while the EMA recommended approval for the drug in anal cancer treatment based on Phase 3 trial data.
Mar 06, 2026
Outlook Therapeutics conducted a Type A meeting with the FDA to discuss the December 30, 2025 Complete Response Letter for ONS-5010/LYTENAVA™, focusing on substantial evidence of effectiveness and potential regulatory paths forward.
Mar 03, 2026
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Moderna's mCOMBRIAX, the world's first combination Covid-19 and influenza vaccine, for individuals 50 years and older.
Mar 02, 2026
Belite Bio announced preliminary Q4 2025 results and plans to submit an NDA for tinlarebant in Q2 2026 following positive Phase 3 trial results. BioArctic reported record financial results with operating profit exceeding SEK 1.2 billion for 2025. Recordati delivered strong preliminary full-year 2025 results despite FX headwinds.
Mar 02, 2026
Samsung Bioepis reached settlement agreements with Regeneron and Bayer for its aflibercept biosimilar OPUVIZ, enabling U.S. launch in January 2027 and staged international rollout beginning early 2026.
