Curated news and analysis on clinical trials, drug approvals, and medical research.
Emergent BioSolutions received FDA approval on Feb. 12, 2026, for 6-count and 24-count multipack configurations of over-the-counter NARCAN Nasal Spray, designed to meet the needs of partners distributing higher volumes of naloxone to community programs.
Samsung Bioepis and Regeneron reached a settlement allowing U.S. launch of Opuviz, an aflibercept biosimilar, in January 2027. The agreement resolves a patent dispute that began in late 2023.
The FDA mandated febrile seizure warnings for flu vaccines and rejected Moderna's mRNA flu vaccine application, with a political appointee overruling agency staff despite no safety concerns identified.
An international research team has identified antibody 007, which targets HIV-1's V3 glycan site without depending on sugar structures the virus frequently alters, remaining effective against resistant variants and enhancing combination therapies.
AAV-based gene therapy offers sustained intraocular delivery of anti-angiogenic agents with a single treatment for neovascular AMD, with leading clinical candidates including RGX-314, ADVM-022, 4D-150, and NG101.
Vertex Pharmaceuticals reported fourth quarter 2025 revenue of $3.19 billion, up 10% year-over-year, and provided full year 2026 revenue guidance of $12.95 billion to $13.1 billion with over $500 million expected from non-CF products.
Vistagen reported fiscal Q3 2026 results with $61.8 million in cash as of December 31, 2025, while advancing its PALISADE-4 Phase 3 trial of fasedienol for social anxiety disorder and preparing an IND submission for refisolone in menopause symptoms.
Bio-Rad Laboratories reported Q4 2025 revenue of $693.2 million, up 3.9%, driven by Clinical Diagnostics growth, while Life Science sales declined 2.6% due to constrained academic and biotech funding. Gross and operating margins fell below expectations.
MoonLake Immunotherapeutics announced positive topline results from its Phase 2 S-OLARIS trial of sonelokimab in axial spondyloarthritis, with 81% of patients achieving ASAS40 response by Week 12. The company ended Q4 2025 with $394 million in cash.
California-based Centivax has begun dosing participants in a Phase 1A clinical trial of Centi-Flu 01, a universal influenza vaccine designed to target conserved viral regions across all flu strains. Initial data from approximately 180 participants is expected within the year.
Multiple law firms have filed securities class actions against Inovio Pharmaceuticals after the FDA accepted its INO-3107 BLA for standard rather than accelerated review, following earlier manufacturing delays with the CELLECTRA device.
Moderna reported Q4 2025 revenue of $700 million and full-year revenue of $1.9 billion, beating estimates while cutting operating expenses by $2.2 billion. The FDA refused to file the company's seasonal flu vaccine application.
The FDA approved Novocure's Optune Pax device for locally advanced pancreatic cancer treatment alongside chemotherapy, marking the first new treatment option in this indication since 1996. Phase III trial data showed statistically significant survival improvement.
Researchers in China and Australia have identified distinct mechanisms to improve cancer immunotherapy effectiveness, addressing why up to 60% of patients fail to respond to immune checkpoint blockade therapy.
The FDA approved pembrolizumab plus paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian cancer based on phase 3 KEYNOTE-B96 trial results showing improved survival outcomes.
The FDA has approved Optune Pax, a wearable device delivering tumor treating fields for locally advanced pancreatic cancer. The approval marks the first new treatment modality for this indication in nearly 30 years.
Eli Lilly announced a $2.4 billion acquisition of Orna Therapeutics and multiple partnerships to expand its drug pipeline beyond its blockbuster GLP-1 franchise into cell and genetic therapies.
Study finds FDA-approved drug AMD3100 can mobilize immune T cells to attack fibrolamellar carcinoma, a rare liver cancer affecting children and young adults that has resisted immunotherapy treatment.
Artificial intelligence is increasingly used to analyze Alzheimer's datasets and inform drug discovery, while researchers identify promising new drug targets including the IDOL enzyme and somatostatin receptors that could lead to more affordable treatments.
Immunotherapy is increasingly being used before and after surgery across seven cancer types, while the global immunotherapy drugs market experiences significant growth driven by advances in biotechnology and targeted therapies.
