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May 18, 2026
Baxfendy was approved in the US for hypertension in adults not adequately controlled on other antihypertensive medicines. The approval was based on Phase III BaxHTN results showing significant systolic blood pressure reductions.
May 09, 2026
Three advances in TB diagnostics: a portable $300 device delivering results in 30 minutes, a Quick DNA kit detecting drug resistance in 5 minutes, and an ultrasensitive test finding TB DNA in 12-16% of hospitalized US patients.
May 06, 2026
New therapies including CAR-T, bispecific antibodies and dual-antibody immunotherapy are reshaping multiple myeloma care. Advances in genomic testing may also improve risk assessment and treatment decisions.
May 02, 2026
Vermont insurers and employers are scaling back GLP-1 coverage as costs rise, leaving some patients without access. The drugs remain in high demand as studies point to benefits beyond weight loss.
May 02, 2026
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
Apr 24, 2026
A study in stage 3 dMMR colon cancer found that atezolizumab plus chemotherapy after surgery cut recurrence and death risk by 50%. The trial enrolled 712 patients and the regimen is now included in treatment guidelines.
Apr 18, 2026
The FDA plans to make one study the default for some new drug approvals instead of two robust clinical trials. The shift could have its biggest effect on drugs for common ailments.
Apr 17, 2026
The European Commission approved Enflonsia for prevention of RSV lower respiratory tract disease in infants during their first RSV season. Merck also reported new Phase 3 SMART data showing generally consistent second-season safety in high-risk children under 2 years old.
Apr 09, 2026
A paper in the New England Journal of Medicine argues the Supreme Court should reject FDA-required drug labels as standalone evidence of patent infringement in Hikma Pharmaceuticals USA v. Amarin Pharma. The paper says lower-court guidance raises liability risk for generic-drug manufacturers complying with FDA rules and could hamper competition.
Apr 02, 2026
The FDA will drop its longtime requirement for two rigorous studies to approve new drugs, moving to a default position of requiring only one study. Commissioner Marty Makary says the change reflects modern scientific advances and aims to accelerate drug availability without compromising safety. The shift follows decades of increasing flexibility for rare and fatal diseases, with about 60% of first-of-a-kind drugs already approved based on single studies in recent years.
Apr 02, 2026
Pharmaceutical M&A is shifting toward late-stage clinical assets with proven human data, particularly in GLP-1 obesity drugs, oncology, and central nervous system disorders. Companies like Viking Therapeutics, Structure Therapeutics, and Revolution Medicines represent compelling acquisition targets with advanced clinical programs. This trend reflects industry prioritization of de-risked assets that can accelerate commercialization pathways.
Mar 30, 2026
Mavacamten significantly reduces heart obstruction in adolescents with hypertrophic cardiomyopathy, with patients experiencing a 48.5 mm Hg drop in blockage compared to minimal change in placebo groups. The drug also lowered blood markers indicating heart damage and showed promise in slowing disease progression. Separate real-world data confirms mavacamten's effectiveness as monotherapy across diverse patient populations.
Mar 29, 2026
Priovant Therapeutics' brepocitinib demonstrated significant efficacy in the Phase 3 VALOR trial for dermatomyositis, meeting its primary endpoint with a 15.3-point greater improvement in Total Improvement Score versus placebo at Week 52. The treatment showed meaningful corticosteroid tapering and improvements across all nine key secondary endpoints, with benefits sustained through one year. Additional analyses revealed rapid itch reduction and improved skin-related quality of life in patients.
Mar 24, 2026
Legal scholars argue FDA-required drug labels should not serve as evidence in patent infringement cases against generic manufacturers. The Supreme Court will hear a case involving this "infringement by label" theory, which could clarify that regulatory compliance alone doesn't prove patent violation. This approach threatens affordable generic drug access by creating liability for companies following FDA rules.
Mar 12, 2026
BioVersys has dosed the first patient in a Phase 2b trial evaluating alpibectir-ethionamide (AlpE) in combination with first-line TB drugs, following promising Phase 2a results published in the New England Journal of Medicine.
Mar 06, 2026
The FDA approved Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma in March 2026, and Darzalex Faspro-based quadruplet D-VRd for newly diagnosed transplant-ineligible patients in January 2026.
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 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 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 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.
