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Feb 23, 2026
BioNTech filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging the company's newly approved mNEXSPIKE vaccine uses proprietary mRNA technology without authorization.
Feb 23, 2026
Gossamer Bio's seralutinib narrowly missed its primary endpoint in the Phase 3 PROSERA study for pulmonary arterial hypertension, achieving a p-value of 0.0320 versus the prespecified threshold of 0.025, though showing stronger results in intermediate- and high-risk patients.
Feb 24, 2026
ImmunityBio announced $113 million in net product revenue for Anktiva in 2025, a 700% year-over-year increase, while expanding regulatory authorization to 33 countries and securing first approval for lung cancer treatment in Saudi Arabia.
Feb 24, 2026
The FDA has expanded approval of Wakix (pitolisant) to treat cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-controlled substance approved for both pediatric and adult narcolepsy patients with or without cataplexy.
Feb 24, 2026
Eli Lilly reported Q4 2025 EPS of $7.54 versus $6.67 expected and projected 2026 revenue of $80-83 billion. Mounjaro revenue surged 110% to $7.4B while Zepbound jumped 123% to $4.2B in Q4.
Feb 23, 2026
The FDA has accepted Ultragenyx's BLA for DTX401, an AAV gene therapy for Glycogen Storage Disease Type Ia, granting Priority Review with a PDUFA action date of August 23, 2026.
Feb 24, 2026
The global CRISPR and prime editing market is forecast to grow at 24.1% CAGR through 2031, driven by therapeutic advances and regulatory progress. Scribe Therapeutics achieved a second milestone with Eli Lilly, while new RNA production and gene editing technologies accelerate research.
Feb 23, 2026
The FDA approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration regimen for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma, based on Phase 3 AMPLIFY trial results.
Feb 23, 2026
iRegene Therapeutics has dosed the first U.S. patient in a Phase IIa trial of NouvNeu001 for Parkinson's disease and enrolled the first patient in a China trial of NouvNeu004 for Multiple System Atrophy.
Feb 23, 2026
The FDA has accepted for review Beren Therapeutics' NDA for adrabetadex in infantile-onset Niemann-Pick disease type C with a PDUFA date of August 17, 2026, and Dr. Reddy's BLA for a biosimilar to Orencia (abatacept).
Feb 23, 2026
Ocular Therapeutix announced positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting its primary endpoint with statistically significant improvements in vision outcomes compared to aflibercept.
Feb 23, 2026
Stoke Therapeutics presented long-term Dravet syndrome data showing up to 80% seizure reductions sustained through three years, outlined its Phase 3 EMPEROR trial design targeting mid-2027 data, and disclosed first patient dosing in its ADOA program.
Feb 23, 2026
Benitec Biopharma will present interim clinical study results for BB-301 gene therapy in oculopharyngeal muscular dystrophy patients at the Muscular Dystrophy Association Conference on March 9, 2026, including 12-month and 24-month follow-up data.
Feb 23, 2026
CagriSema demonstrated 23% weight loss in the REDEFINE 4 trial but failed to meet its primary endpoint of non-inferiority compared to tirzepatide's 25.5% weight loss. The company submitted an FDA application in December 2025 based on earlier pivotal trials.
Feb 23, 2026
Novo Nordisk's experimental weight loss drug CagriSema achieved 23% weight loss after 84 weeks compared to 25.5% with Eli Lilly's tirzepatide in a head-to-head Phase 3 trial, sending Novo shares down 15% in Copenhagen.
Feb 23, 2026
Two clinical trials demonstrate efficacy of talimogene laherparepvec (T-VEC) oncolytic virus therapy in HER2-negative breast cancer and nonmelanoma skin cancers, with favorable safety profiles and durable responses in subset of patients.
Feb 20, 2026
Vanda Pharmaceuticals received FDA approval for Bysanti (milsaperidone), an atypical antipsychotic for schizophrenia and manic or mixed episodes in bipolar I disorder. The drug will be available by the third quarter of 2026.
Feb 17, 2026
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.
Feb 16, 2026
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
Feb 16, 2026
Gilead Sciences entered a definitive agreement to acquire Arcellx for $115 per share in cash plus a $5 contingent value right, representing an implied equity value of $7.8 billion. The acquisition provides Gilead with full control of anito-cel, an investigational BCMA-directed CAR T-cell therapy for multiple myeloma.
