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Feb 20, 2026
The FDA approved AbbVie's combination of Venclexta and acalabrutinib as the first all-oral, fixed-duration treatment for previously untreated chronic lymphocytic leukemia patients, based on Phase 3 trial data showing 35% reduction in disease progression risk.
Feb 20, 2026
Grail's multi-cancer blood test failed to significantly boost early detection or reduce late-stage diagnoses in a 142,000-person UK trial, raising doubts about regulatory approval and commercial prospects.
Feb 21, 2026
Savara Inc. announced the FDA has accepted its Biologics License Application for Molbreevi to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a PDUFA action date of August 22, 2026.
Feb 20, 2026
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration regimen for previously untreated chronic lymphocytic leukemia, based on phase III AMPLIFY trial results showing 35% reduction in disease progression or death risk versus chemoimmunotherapy.
Feb 21, 2026
The FDA has accepted Teva and Medincell's New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine formulation for schizophrenia treatment that showed no need for post-injection monitoring in Phase 3 trials.
Feb 20, 2026
Barclays initiated coverage on Merck with an overweight rating and $140 price target, citing expected product launches including enlicitide and pivotal trial readouts for tulisokibart in 2026.
Feb 21, 2026
The US FDA has accepted Dr Reddy's Biologics License Application for DRL-AB, a proposed interchangeable biosimilar to Orencia (abatacept) for intravenous infusion, marking the first abatacept biosimilar submission.
Feb 21, 2026
The FDA has accepted Teva and Medincell's New Drug Application for olanzapine extended-release injectable suspension (TEV-'749), a once-monthly subcutaneous treatment for schizophrenia in adults that showed no evidence for post-injection monitoring requirements.
Feb 18, 2026
GLP-1 weight loss drugs show increasing efficacy but raise concerns about excessive weight loss, side effects, and the rise of unregulated compounded versions sold online.
Feb 21, 2026
The FDA has approved BYSANTI (milsaperidone), a new chemical entity for treating bipolar I disorder and schizophrenia in adults. The drug is Vanda's second approval in less than two months and is expected to launch in Q3 2026.
Feb 21, 2026
Vanda Pharmaceuticals announced FDA approval for BYSANTI tablets to treat Bipolar I manic episodes and schizophrenia in adults. The drug has patent protection extending to 2044 and will be commercially available in Q3 2026.
Feb 20, 2026
A Phase II trial led by WVU Cancer Institute reports the first-ever use of subcutaneous blinatumomab in CD19-positive mixed phenotype acute leukemia, with the first patient achieving complete remission after one cycle.
Feb 20, 2026
The FDA has accepted for Priority Review Regeneron's biologics license application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target action date of August 2026.
Feb 18, 2026
59 Republican senators filed an amicus brief supporting Louisiana's lawsuit against the FDA, arguing the agency violated federal law by removing in-person dispensing requirements for mifepristone.
Feb 16, 2026
Savara Inc. announced the FDA has accepted its resubmitted Biologics License Application for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis, with Priority Review granted and a target decision date of August 22, 2026.
Feb 21, 2026
Savara Inc. announced the FDA has filed for review the BLA for MOLBREEVI to treat autoimmune PAP, granting Priority Review with a PDUFA action date of August 22, 2026. The therapy could become the first approved treatment for this rare lung disease.
Feb 20, 2026
The FDA has accepted Roche's New Drug Application for giredestrant plus everolimus to treat ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is based on phase III data showing significant reductions in disease progression risk.
Feb 20, 2026
Candel Therapeutics announced a $100 million royalty funding agreement with RTW Investments, contingent on FDA approval of aglatimagene besadenovec for intermediate- to high-risk localized prostate cancer, with tiered royalties on U.S. net sales.
Feb 20, 2026
PDS Biotechnology adopted an amended protocol for its Phase 3 VERSATILE-003 trial, adding progression-free survival as an interim primary endpoint to support potential accelerated approval of PDS0101 in HPV16-positive head and neck cancer.
Feb 18, 2026
The FDA has approved Harmony Biosciences' Wakix (pitolisant) for treating cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
