Curated news and analysis on clinical trials, drug approvals, and medical research.
Viking Therapeutics has completed enrollment in its Phase 3 VANQUISH-1 trial for injectable VK2735 and plans to advance oral VK2735 into Phase 3, while also filing an IND for a new amylin agonist program targeting obesity.
Vertex Pharmaceuticals and CRISPR Therapeutics reported $116 million in full-year 2025 sales for gene-editing therapy Casgevy, with 64 patients receiving infusions and patient initiations nearly tripling compared to 2024.
Disc Medicine received a complete response letter from the FDA for bitopertin as a treatment for erythropoietic protoporphyria. The FDA acknowledged the drug lowers PPIX levels but requires evidence from the ongoing Phase 3 APOLLO study before approval.
Novartis agrees to sell its 70.68% stake in Indian unit for $159 million to ChrysCapital-led consortium, while parent company shares reach all-time highs with 55% gains over the past year.
Johnson & Johnson shares have climbed 53% over the past year and 15% year-to-date, with RBC Capital and Bank of America raising price targets on the stock amid strong financial performance and 6% revenue growth in 2025.
Moderna challenges FDA's refusal to review its mRNA flu vaccine application, citing shifting regulatory expectations. The company reported Q4 revenue of $678 million as COVID vaccine uptake fell 26% in 2025.
Charles River Laboratories is scheduled to report Q4 2025 results on Feb. 18, with analysts raising price targets while the company navigates biotech funding pressures and announces new gene therapy collaborations.
Immunic announced an oversubscribed private placement of up to $400 million to complete phase 3 trials of vidofludimus calcium in relapsing multiple sclerosis, initiate a phase 3 program in primary progressive MS, and transition to a commercial organization.
Novo Nordisk launched oral Wegovy in January 2026 with strong early uptake, but faces FDA criticism over misleading advertising and legal battles over compounded alternatives as the company projects sales decline for 2026.
The U.S. National Science Foundation announced a $100 million investment to establish up to 16 open-access research sites for quantum and nanoscale technologies over five years, with letters of intent due March 16, 2026.
Congress enacted legislation narrowing orphan drug exclusivity to specific approved uses rather than entire diseases, overriding an 11th Circuit ruling and aligning the statute with FDA's traditional approach.
The global genomics in cancer care market is projected to grow from $24.39 billion in 2025 to $108.69 billion by 2035, driven by rising cancer incidence, personalized medicine adoption, and next-generation sequencing advances.
China Medical System Holdings partnered with Insilico Medicine on AI-powered drug discovery in early February 2026 and received Chinese regulatory approval to begin human trials for complement factor B inhibitor CMS-D017.
A matched analysis of 923 men found salvage focal therapy and radical prostatectomy achieved comparable 10-year cancer-specific survival for prostate cancer recurring after radiotherapy, though surgery carried significantly higher complication rates.
Praxis Precision Medicines is preparing to submit two New Drug Applications by mid-February 2026 for ulixacaltamide and relutrigine, both holding FDA Breakthrough Therapy Designation, targeting essential tremor and epilepsy markets.
Merck stock reached a 52-week high at $122.69, rising 46.25% over 12 months and 7.4% in the past month following strong Q4 results and improved long-term pipeline outlook beyond Keytruda's 2028 patent expiration.
Johnson & Johnson announced 12-month pilot-phase data from the OMNY-AF study showing 100% acute procedural success with zero adverse events in treating symptomatic paroxysmal atrial fibrillation across 30 patients.
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.
A study published in JAMA Cardiology found that semaglutide would be cost-effective for secondary cardiovascular disease prevention in U.S. adults with overweight or obesity at an 18% price reduction or at the current cash price of $5,988 annually.
Sana Biotechnology received an analyst downgrade as the FDA increases regulatory scrutiny on gene therapies, raising questions about the company's cash runway and clinical progress ahead of its mid-March 2026 quarterly update.
