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Feb 25, 2026
The FDA has announced a major policy shift ending the "two-trial dogma," allowing drug approvals based on one adequate and well-controlled study plus confirmatory evidence, with heightened focus on study design quality.
Feb 21, 2026
ImmunityBio receives conditional EU marketing authorization for Anktiva combination therapy in bladder cancer, covering 33 countries, while establishing distribution partnerships in Saudi Arabia for bladder and lung cancer patients.
Feb 24, 2026
Merck announced positive second RSV season findings from the Phase 3 SMART trial evaluating ENFLONSIA (clesrovimab) in infants and children under 2 years at increased risk for severe RSV disease, showing consistent safety and antibody levels similar to healthy infants.
Feb 21, 2026
West Virginia University Cancer Institute has dosed the first patient in a phase 1/2 trial evaluating subcutaneous blinatumomab for CD19-positive mixed-phenotype acute leukemia, a rare disease with no FDA-approved therapies. The first patient achieved complete remission after one cycle.
Feb 20, 2026
FDA Commissioner Marty Makary identified hospital contracting, IRB processes, and IND application timelines as key bottlenecks slowing US early-phase trials. China now conducts more clinical trials than the US and accounts for nearly a third of new global drug approvals.
Feb 19, 2026
A comprehensive market report reveals over 180 companies are developing more than 200 PD-1 and PD-L1 inhibitor drugs, with recent fast-track designations and successful Phase III trial results driving expansion in cancer immunotherapy.
Feb 20, 2026
The European Commission has approved a new 7.2 mg once-weekly maintenance dose of Wegovy (semaglutide injection) for adults with obesity, providing physicians with an additional treatment option for patients requiring further weight reduction after the 2.4 mg dose.
Feb 19, 2026
Orca-T, an investigational T-cell therapy under FDA priority review, is being studied to reduce graft-versus-host disease in patients undergoing allogeneic stem cell transplant for acute leukemias and high-risk blood disorders, with a decision expected in April 2026.
Feb 18, 2026
A House Energy and Commerce subcommittee hearing on Feb. 11 revealed sharp partisan divisions over drug pricing solutions, with Republicans focusing on PBM reform and supply chain transparency while Democrats defended existing price negotiation policies and warned of threats from research funding cuts.
Feb 26, 2026
Zydus Lifesciences plans to launch Semaglutide injection in India after patent expiry and introduced ANYRA, India's first indigenous Aflibercept biosimilar. The USFDA cleared the company's Ahmedabad injectable facility with zero observations.
Feb 26, 2026
The FDA has proposed a new "plausible mechanism" pathway to approve customized treatments for rare diseases after testing in only a handful of patients, aiming to remove barriers for gene editing and other bespoke therapies that don't fit traditional approval systems.
Feb 26, 2026
Orphan drug development faces structural uncertainty due to small patient populations and varying global definitions, with regulators balancing early access against evidence requirements through accelerated pathways and post-market monitoring.
Feb 26, 2026
AstraZeneca's CALQUENCE received FDA approval as the first all-oral, fixed-duration regimen for chronic lymphocytic leukemia, while the EMA validated the marketing authorization application for ENHERTU in HER2-positive breast cancer treatment.
Feb 26, 2026
Eli Lilly's oral GLP-1 drug orforglipron demonstrated 6-8% weight loss in type 2 diabetes patients compared to 4-5% with oral semaglutide in a phase 3 trial, though discontinuation rates were higher due to gastrointestinal side effects.
Feb 15, 2026
NanoViricides has filed an orphan drug designation application with the FDA for NV-387 as a measles treatment, amid rising U.S. cases that reached 2,251 in 2025 with 3 deaths and 727 cases already reported in early 2026.
Feb 23, 2026
China's brain-computer interface industry is rapidly commercializing with strong policy support, including an $165 million government fund and provincial medical pricing systems. The market is projected to reach $530 million in 2025 and over 120 billion yuan by 2040.
Feb 20, 2026
Drug discovery is expanding beyond traditional protein targets to include RNA-targeting small molecules, cell surface proteins, and sequence-based AI platforms capable of screening billions of candidates across the entire genome.
Feb 24, 2026
The FDA's Center for Biologics Evaluation and Research issued a refusal-to-file letter to Moderna for its investigational influenza vaccine mRNA-1010, citing concerns over the Phase 3 trial control arm and whether it reflected the best-available standard of care.
Feb 26, 2026
Four biotech companies went public in one week raising nearly $1 billion, signaling a potential thaw in IPO markets after years of quiet activity. Regional life sciences hubs outside Boston and San Francisco are attracting record venture funding, while regulatory uncertainty at FDA continues to concern industry leaders.
Feb 26, 2026
Moderna's seasonal influenza vaccine candidate mRNA-1010 receives FDA acceptance after initial refusal, with a PDUFA date set for August 5, 2026. The revised application proposes full approval for adults 50-64 and accelerated approval for those 65 and older.
