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US FDA Approves Additional Indication for CAPVAXIVE
The US Food and Drug Administration (FDA) has approved an expanded indication for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for children and adolescents aged 2-17 years at increased risk of pneumococcal disease, broadening protection against serious pneumococcal infections in vulnerable pediatric populations.
Oncoinvent has reached the halfway enrollment point in its Phase 2 trial of Radspherin, an experimental alpha-radiation therapy for ovarian cancer patients with peritoneal metastases, as recruitment accelerates across multiple international clinical sites.
Biogen to Acquire RayThera in Deal Worth Up to USD 1 Billion to Strengthen Immunology Pipeline
Biogen has agreed to acquire immunology-focused biotech firm RayThera in a deal worth up to USD 1 billion, gaining a portfolio of anti-inflammatory drug candidates and strengthening its pipeline for immune-mediated diseases.
Chugai Files Regulatory Application in Japan for IgA Nephropathy Drug Sparsentan
Chugai Pharmaceutical has applied for regulatory approval in Japan for sparsentan, a dual-action oral therapy for IgA nephropathy. Clinical studies showed significant reductions in proteinuria and potential benefits in preserving kidney function, offering hope for patients with limited treatment options.
Chiesi Presents New Metreleptin Data and Patient Care Insights at ENDO 2026
Chiesi Global Rare Diseases presented five new studies at ENDO 2026, highlighting advances in metreleptin therapy for lipodystrophy, potential combination treatments, and the urgent need to address mental health challenges and care gaps among patients with the rare disorder.
Mabwell Presents Clinical Data for Nectin-4 ADC 9MW2821 at ESMO 2026
Clinical studies presented at the 2026 ESMO Gynecological Cancers Congress showed that Mabwell’s Nectin-4-targeting ADC 9MW2821 demonstrated a manageable safety profile, promising efficacy, and notable survival benefits in cervical cancer patients, with encouraging antitumor activity when combined with a PD-1 inhibitor.
Regulators Warn against Promotion of Newly Licensed Weight-Loss Medicines
MHRA, ASA, and GPhC have warned businesses against promoting newly licensed prescription-only and unlicensed weight-loss medicines, reinforcing compliance with advertising regulations and public health protections.
Alembic Pharmaceuticals Announces US FDA Tentative Approval for Binimetinib Tablets, 45 mg
Alembic Pharmaceuticals has received the US Food and Drug Administration (FDA) tentative approval for Binimetinib Tablets 45 mg, a generic version of Mektovi (binimetinib).
Innoviva Specialty Therapeutics Signs Licensing Deal with Dr. Reddy's for XACDURO
Innoviva Specialty Therapeutics and Dr. Reddy’s have entered a distribution and licensing agreement to expand access to XACDURO for serious Acinetobacter infections across South and Central America, the Caribbean, Russia, and CIS countries.
US FDA Approves Utebzi for Adult Patients with Complicated UTIs
The US Food and Drug Administration (FDA) has approved GSK’s Utebzi (tebipenem pivoxil) for adults with complicated Urinary Tract Infections (cUTIs), becoming the first and only oral carbapenem antibiotic available. The approval is based on the phase 3 PIVOT-PO trial, which demonstrated non-inferiority to standard intravenous antibiotic treatment.
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