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Feb 17, 2026
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.
Feb 20, 2026
The FDA has approved a supplemental new drug application for the combination regimen of Venclexta (venetoclax) and acalabrutinib for previously untreated adult patients with chronic lymphocytic leukemia, supported by Phase 3 AMPLIFY trial data.
Feb 21, 2026
The U.S. Food and Drug Administration has cleared FluoGuide's Investigational New Drug application for FG001, enabling the company to proceed with a Phase 2 registration trial in high-grade glioma patients with first enrollment expected in Q2 2026.
Feb 18, 2026
Novartis reported positive Phase III RemIND trial results showing remibrutinib achieved complete response in three types of chronic inducible urticaria. The company has submitted a supplemental New Drug Application to the FDA for symptomatic dermographism.
Feb 20, 2026
FDA approves AstraZeneca's Calquence plus venetoclax as first all-oral, 14-month fixed-duration regimen for first-line chronic lymphocytic leukemia, with 77% of patients progression-free at three years in Phase III trial.
Feb 20, 2026
Researchers at Washington University School of Medicine developed a blood test-based method to predict when Alzheimer's symptoms will begin, with accuracy within three to four years, using plasma p-tau217 protein levels.
Nov 17, 2025
The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.
Feb 17, 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.
Feb 21, 2026
The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' Bysanti for treating schizophrenia and acute bipolar I disorder. The company expects to launch the drug in the third quarter of 2026.
Feb 17, 2026
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.
Feb 19, 2026
Moderna announced the FDA will consider approving its mRNA-based flu vaccine for older adults after resolving a dispute over clinical trial design. The vaccine showed 34.5% higher efficacy than standard flu shots in trials.
Feb 22, 2026
Bristol Myers Squibb faces a steep patent cliff with key drugs losing protection between 2027-2029, but newer products like Cobenfy show promise. The stock trades at less than 10 times earnings with a 4.2% dividend yield.
Feb 21, 2026
Dr. Reddy's Laboratories secures FDA acceptance for DRL-AB, the first abatacept biosimilar application in the U.S., targeting a market worth $3.7 billion annually and positioning the company for first-mover advantage.
Feb 18, 2026
uniQure N.V. faces a securities fraud class action lawsuit after disclosing the FDA no longer agreed its AMT-130 data was adequate for approval, causing a 49% stock decline. Investors have until April 13, 2026 to file lead plaintiff applications.
Feb 13, 2026
Researchers have developed attenuated Listeria bacteria therapies that boost innate immune cells to fight cancer. Two approaches target colorectal cancer and pediatric leukemia, with FDA clearance expected soon for trials in children.
Feb 21, 2026
Long-term data from the QUASAR extension study show TREMFYA® maintained clinical remission in over 80% of ulcerative colitis patients at Week 140, with more than half achieving endoscopic remission and no new safety concerns observed.
Feb 20, 2026
The FDA has accepted Teva Pharmaceutical's New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine extended-release injectable suspension for treating schizophrenia in adults, supported by Phase 3 SOLARIS trial data.
Feb 18, 2026
Twenty-one state attorneys general and 60 members of Congress filed amicus briefs supporting Louisiana's lawsuit challenging the FDA's 2023 policy that removed in-person dispensing requirements for mifepristone, enabling mail-order distribution of abortion drugs.
Feb 16, 2026
The FDA approved an oral version of Wegovy in December 2025, providing a pill alternative to injections. Clinical trials showed comparable effectiveness between oral and injectable forms of semaglutide for weight loss.
Feb 13, 2026
Major pharmaceutical companies are highlighting their drug pipelines to offset upcoming patent losses, while Moderna confronts FDA rejection of its flu vaccine. The industry faces significant revenue challenges from patent cliffs in 2026.
