Curated news and analysis on clinical trials, drug approvals, and medical research.
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.
Xenon Pharmaceuticals will announce topline data from its Phase 3 X-TOLE2 study of azetukalner in patients with focal onset seizures on March 9, 2026, during a conference call at 8:00 a.m. ET.
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.
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.
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.
Nigeria's National Biosafety Management Agency reassures citizens that no GMO food is approved without thorough safety assessment, while critics question the absence of long-term independent risk studies and transparency in the regulatory process.
New research reveals GPs spend only 56% of their time with patients, while 31% goes to non-contact clinical work that remains largely unfunded, contributing to workforce burnout and retention issues.
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.
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.
Orforglipron, an oral GLP-1 receptor agonist, demonstrated greater reductions in HbA1c and body weight compared to oral semaglutide in adults with type 2 diabetes, with more patients achieving strict glycemic targets at one year.
Novartis announced positive European regulatory opinion for remibrutinib in chronic spontaneous urticaria and reported the drug met its primary endpoint in a Phase 3 trial for chronic inducible urticaria.
