Curated news and analysis on clinical trials, drug approvals, and medical research.
A UCLA study found that adding immunotherapy to chemotherapy before surgery is safe for borderline-resectable pancreatic cancer patients, with a subset experiencing complete tumor regression despite no overall survival advantage.
Moderna received European Commission marketing authorization for its COVID-19 vaccine mNEXSPIKE for individuals aged 12 and older. The FDA also reversed its decision and agreed to review the company's seasonal flu vaccine application.
Semaglutide and other GLP-1 receptor agonists demonstrate substantial weight loss effectiveness through appetite regulation and blood sugar control, with clinical studies showing average reductions of 14.9% to 20.9% body weight.
Two financial services firms raised their price targets for Moderna in mid-February 2026, with RBC Capital increasing its target to $30 and Evercore ISI Group raising its target to $35, both maintaining neutral ratings.
The FDA approved Harmony Biosciences' supplemental new drug application for WAKIX (pitolisant) to treat cataplexy in pediatric patients 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
Pfizer announced positive progression-free survival results from the BREAKWATER trial evaluating Braftovi in combination with cetuximab and Folfiri in previously untreated metastatic colorectal cancer patients with BRAF V600E mutation.
Novo Nordisk secured FDA approval for oral Wegovy tablets in December 2025 and subsequently sued telehealth company Hims & Hers for patent infringement over compounded versions. The company is the only manufacturer with an FDA-approved GLP-1 weight loss pill.
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.
Aspire Biopharma filed a provisional patent application for a sublingual powder formulation of meclizine on February 17, 2026, designed to reduce onset time from 60 minutes to minutes. The company plans a 505(b)(2) regulatory pathway for the antiemetic targeting a $450 million global market.
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.
