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Mar 09, 2026
GSK agreed to license linerixibat to Alfasigma in a deal worth up to $690 million, while Eisai received orphan drug designation in Japan for E2086, a novel selective orexin 2 receptor agonist for narcolepsy.
Mar 09, 2026
Novo Nordisk dismissed its patent infringement lawsuit against Hims & Hers after the companies reached an agreement to sell branded Wegovy and Ozempic through the Hims platform. The settlement ends a dispute that began when Hims planned to offer a cheaper off-brand version of Wegovy.
Mar 09, 2026
Sequel Med Tech and Senseonics announced full U.S. availability of the twiist Automated Insulin Delivery System integrated with the Eversense 365 CGM, the world's only one-year continuous glucose monitor, for people with type 1 diabetes.
Mar 09, 2026
Pfizer's tilrekimig met its primary endpoint in a mid-stage eczema trial and will advance to late-stage testing. Separately, oral remibrutinib demonstrated rapid efficacy in treating peanut allergy in a phase II study.
Mar 09, 2026
OS Therapies progresses toward Accelerated Approval for OST-HER2 in osteosarcoma, with FDA elevating meeting status and global regulatory submissions on track for Q1 2026.
Mar 09, 2026
Precision BioSciences announced FDA Fast Track designation for PBGENE-DMD, a first-in-class gene editing therapy for Duchenne muscular dystrophy targeting mutations in exons 45-55, representing up to 60% of DMD patients.
Mar 09, 2026
ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.
Mar 09, 2026
OS Therapies progresses toward Accelerated Approval for OST-HER2 in osteosarcoma, with FDA elevating meeting status and global regulatory submissions on track for Q1 2026.
Mar 09, 2026
FDA elevated OS Therapies' Type D meeting to Type B pre-BLA meeting for OST-HER2 in osteosarcoma, signaling transition to Accelerated Approval discussions. Clinical data submission targeted for end of Q1 2026.
Mar 09, 2026
The FDA has accepted a supplemental new drug application for aminolevulinic acid hydrochloride plus red light therapy for superficial basal cell carcinoma, with a decision date set for September 28, 2026.
Mar 09, 2026
Five intra-articular gene therapy platforms for knee osteoarthritis are in human trials in the US, while India prepares regulatory guidelines for mRNA, gene and cell therapies to accelerate innovation.
Mar 09, 2026
The FDA has approved topical difamilast, a PDE4 inhibitor, for treating mild-to-moderate atopic dermatitis in adults and children aged 2 years or older, marking the third PDE4 inhibitor approval for this indication.
Mar 09, 2026
The FDA approved Bracco's Vueway for neonates and infants at half the standard gadolinium dose, accepted Bayer's gadoquatrane application for a 60% dose reduction, and granted Breakthrough Device designation to Radiology Partners' AI chest X-ray tool.
Mar 09, 2026
Rhythm Pharmaceuticals announced expanded Phase 3 TRANSCEND trial data showing an 18.8% placebo-adjusted BMI reduction at 52 weeks for setmelanotide in acquired hypothalamic obesity, with FDA PDUFA goal date set for March 20, 2026.
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.
Mar 09, 2026
Compass Pathways announced positive Phase 3 data for COMP360 psilocybin therapy in treatment-resistant depression, showing statistically significant improvements in depression scores and durability through 26 weeks, with plans to file for FDA approval in Q4 2026.
Mar 09, 2026
COMPASS Pathways announced positive Phase 3 results for COMP360 psilocybin in treatment-resistant depression, showing statistically significant improvements across two pivotal trials with durability signals through 26 weeks and a generally well-tolerated safety profile.
Mar 08, 2026
Healthcare sector surged 10% since Q4 2025, outpacing all S&P 500 sectors as investors rotate from tech to pharmaceutical value plays. Major drugmakers demonstrate resilience following Medicare price negotiations implementation.
Mar 08, 2026
More than 16,000 dermatology trials were completed, ongoing, or planned by the end of 2025, with the Asia-Pacific region experiencing a nearly five-fold increase over the past decade. The field now accounts for around 8,000 trials in Asia-Pacific alone, matching North America and Europe combined.
Mar 08, 2026
Pfizer is applying lessons from its Viagra launch to introduce its first obesity treatment, a monthly injection acquired from Metsera. The company aims to leverage past experience with sensitive health topics as it enters the competitive obesity market.
