Curated news and analysis on clinical trials, drug approvals, and medical research.
Grail's NHS-Galleri trial of 142,000 participants failed to achieve statistically significant reduction in late-stage cancer diagnoses, though secondary endpoints showed four-fold improvement in overall cancer detection rate. Stock fell 48% following the announcement.
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.
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.
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.
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.
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.
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.
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.
Precision BioSciences receives FDA Fast Track designation for PBGENE-DMD, a gene editing therapy for Duchenne muscular dystrophy designed to treat patients with mutations in exons 45-55.
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.
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.
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.
Regulatory authorities in the US and EU are proposing measures to reduce clinical data requirements and streamline approval processes for biosimilar drugs, aiming to accelerate access to lower-cost alternatives to biologic medications.
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.
Roche reported its Phase III MAJESTY study in primary membranous nephropathy met its primary endpoint with Gazyva/Gazyvaro, positioning the medicine as a potential first approved treatment for this rare kidney condition.
Eli Lilly's weight-loss drug Mounjaro fueled sevenfold sales growth in Brazil and doubled sales in India within months of launch, as the company commits $1 billion to make India a global export hub for its supply chain.
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.
Pharmac has proposed expanding access to melanoma treatments and funding two new therapies for chronic lymphocytic leukaemia. Medical researchers also highlight that New Zealanders lack access to CAR T-cell therapy domestically.
Dianthus Therapeutics will host a conference call on March 9, 2026, to discuss interim responder analysis results from Part A of the Phase 3 CAPTIVATE trial of claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
A major meta-analysis of 19 randomized trials involving 123,940 participants found that only six side effects are actually caused by statins, challenging long-standing concerns about the drugs' safety profile.
