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Feb 20, 2026
Switzerland-based CRISPR Therapeutics stands to benefit from increased Casgevy sales following partner Vertex Pharmaceuticals' fourth-quarter results, with five additional gene-editing therapies in clinical trials targeting larger patient populations.
Feb 19, 2026
The UK and US announced a pharmaceuticals agreement featuring zero tariffs and a 25% increase in UK spending on innovative medicines. Major pharma M&A deals and regulatory reforms are reshaping the industry in early 2026.
Feb 20, 2026
The FDA has accepted Roche's new drug application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated breast cancer, with a decision expected by December 18, 2026.
Feb 17, 2026
Semaglutide and other GLP-1 receptor agonists demonstrate substantial weight loss effectiveness through appetite regulation and blood sugar control, with clinical studies showing average reductions of 14.9% to 20.9% body weight.
Feb 17, 2026
Moderna posted Q4 2025 revenue of $678 million, beating analyst estimates despite a 29.8% year-over-year decline. The company reduced operating expenses by 31% while facing FDA refusal to file its flu vaccine application.
Feb 20, 2026
The FDA has approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration BTK inhibitor-based regimen for previously untreated adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
Feb 20, 2026
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
Feb 20, 2026
The FDA has accepted a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.
Feb 20, 2026
The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.
Feb 20, 2026
Eli Lilly's Omvoh demonstrated durable efficacy in Crohn's disease, with over 90% of patients maintaining steroid-free clinical remission through three years of monthly treatment in the Phase III VIVID-2 extension study.
Feb 20, 2026
The FDA will now require a single pivotal clinical trial as the default for novel medicine approvals, replacing its decades-old two-trial standard. The policy aims to reduce development costs and accelerate innovation.
Feb 19, 2026
The FDA announced it will generally require only one pivotal trial for drug approvals, ending the decades-old two-trial standard. The policy aims to reduce development costs and speed market access while maintaining focus on trial quality.
Feb 19, 2026
The European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer, expanding the therapy's availability to 33 countries across four regulatory jurisdictions.
Feb 17, 2026
Compass Pathways announced positive results from its second Phase 3 trial of synthetic psilocybin COMP360 for treatment-resistant depression, showing a 3.8-point reduction in depression scores. The company plans to meet with the FDA to discuss a rolling approval application.
Feb 16, 2026
The U.S. Food and Drug Administration has approved an Investigational New Drug application for FRF-001, a viral gene therapy for FOXG1 syndrome developed at the University at Buffalo. The first-in-human trial will be independently sponsored by the FOXG1 Research Foundation.
Feb 20, 2026
The FDA has approved the combination of Venclexta (venetoclax) plus acalabrutinib as the first all-oral, fixed-duration regimen for previously untreated adults with chronic lymphocytic leukemia, based on Phase III AMPLIFY study results.
Feb 20, 2026
NEXT Life Sciences has advanced two male birth control options into Phase II clinical trials: Plan A™, a long-acting reversible system, and NLS-133, a non-hormonal pill designed for on-demand or daily use.
Feb 20, 2026
PureTech Health announced that deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for idiopathic pulmonary fibrosis, with a Phase 3 trial planned for the first half of 2026.
Feb 20, 2026
PureTech Health's deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for treating idiopathic pulmonary fibrosis, a rare and fatal lung disease. Phase 2b trial results showed superior efficacy compared to existing therapies.
Feb 20, 2026
The U.S. Court of Appeals for the Federal Circuit ruled that Teva Pharmaceuticals did not infringe Corcept Therapeutics' patents for methods of safely co-administering Korlym with CYP3A4 inhibitors, affirming a 2023 district court verdict.
