Curated news and analysis on clinical trials, drug approvals, and medical research.
Moderna faces a pivotal transition from pandemic-era revenues to a diversified mRNA portfolio, with recent regulatory setbacks offset by strong RSV vaccine performance and upcoming Phase 3 oncology readouts.
Sana Biotechnology appointed Brian Piper as Executive Vice President and Chief Financial Officer on February 17, 2026. Piper brings over 25 years of biopharmaceutical financial expertise to the cell and gene therapy company.
Disc Medicine will pursue traditional U.S. approval for bitopertin after the FDA declined to approve the rare disease drug under an accelerated review pathway, with a potential decision expected around mid-2027.
March of Dimes awarded the 2026 Richard B Johnston Jr, MD Prize to hematologist Leonard Zon for pioneering zebrafish research that illuminated blood development in embryos and led to breakthrough treatments for genetic blood disorders in children.
Bon Natural Life announced development of an AI-enabled apple polyphenol facial mask targeting the $100 billion anti-aging market and inaugurated a joint laboratory with Chang'an Pilot for bio-manufactured natural ingredients.
The U.S. Food and Drug Administration has granted 510(k) clearance for Argos Infinity, Retia Medical's cardiovascular intelligence software platform designed for high-risk surgical and critical care environments across health systems.
Cyrano Therapeutics announced positive Phase 2 FLAVOR trial results for CYR-064, an intranasal spray for persistent post-viral hyposmia. The trial met primary safety and secondary efficacy endpoints, supporting Phase 3 development in 2H 2026.
Moleculin Biotech announced the Japan Patent Office has issued a notice of allowance for a patent covering proprietary methods for reconstituting liposomal Annamycin, strengthening the company's international intellectual property position.
Dr Reddy's Laboratories plans to launch a generic version of Novo Nordisk's Wegovy at 60% below the branded price, pending regulatory approval. The company recently received approval for generic Ozempic.
TuHURA Biosciences filed an IND application with the FDA for TBS-2025, a VISTA inhibiting antibody, to be studied in combination with a menin inhibitor for treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia.
Pharmaceutical companies are prioritizing de-risked, late-stage assets with human clinical validation over early-stage programs. Oncology and CNS programs have emerged as strategic M&A targets due to large commercial markets and significant unmet medical needs.
Andelyn Biosciences has been selected by Drake Rayden Foundation to manufacture clinical grade AAV gene therapy for Nonketotic Hyperglycinemia (NKH), a rare inherited metabolic disorder caused by a GLDC gene mutation.
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
Teva and Sanofi reported positive 44-week data from the RELIEVE UCCD long-term extension study of duvakitug, showing durable efficacy in ulcerative colitis and Crohn's disease patients.
Compass Pathways reported positive phase 3 results for COMP360 psilocybin in treatment-resistant depression, showing statistically significant symptom reduction. The company plans to discuss FDA filing with a New Drug Application expected in Q4 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.
Novo Nordisk sues telehealth companies over compounded weight-loss drugs as employers explore AI-based alternatives to costly GLP-1 medications. About 1 in 8 Americans now take GLP-1 drugs for weight loss or diabetes.
Janux Therapeutics has dosed the first participant in a Phase 1 clinical trial of JANX011, a CD19-targeted bispecific candidate designed using its ARM platform for autoimmune disease treatment.
Cyclerion Therapeutics received positive FDA feedback on its Phase 2 study design for CYC-126, an anesthetic-based therapy with real-time EEG monitoring for treatment-resistant depression, with study initiation planned for second half of 2026.
