Curated news and analysis on clinical trials, drug approvals, and medical research.
FDA approved subcutaneous isatuximab-irfc for multiple myeloma. Phase 3 EMN24 trial showed 77% MRD negativity with Isa-KRd quadruplet therapy. Phase 2 study showed 77% hematologic response rate in relapsed/refractory AL amyloidosis.
Phase I CARLYSLE trial data show CAR-T therapy obe-cel induces remission in severe refractory lupus with a favorable safety profile. Separate case report documents two successful pregnancies after dual-target CAR-T therapy with no transmission to infants.
Keenova's Xiaflex met its primary and secondary endpoints in a Phase 3 trial for plantar fibromatosis. The company plans to file for FDA approval before year-end. A separate real-world evidence manuscript highlighted the lack of approved nonsurgical options for the condition.
Phase III data show deramiocel slowed upper limb decline by 54% in Duchenne muscular dystrophy. The FDA is re-evaluating the BLA with HOPE-3 results, with a submission of the clinical study report expected in February 2026.
Longeveron's DMC recommended completing the Phase 2b ELPIS II HLHS trial with no safety concerns; top-line results expected August 2026. The company also appointed a new CEO and announced cost-cutting measures.
University of Galway researchers identified that targeting GABA signaling, specifically α5-GABA A receptors, can restore neural balance and improve memory in Alzheimer's disease models, offering a potential new therapeutic approach distinct from current excitatory-focused treatments.
MEDIPOST treated the first U.S. participant in a Phase III trial of its umbilical cord blood-derived MSC therapy for knee osteoarthritis. The FDA agreed the single pivotal study, supported by prior trials in South Korea and Japan, can support a planned BLA filing.
FDA clears SkinStylus for periorbital wrinkles across all skin types; accepts Biofrontera's sNDA for Ameluz PDT in superficial BCC with a September 2026 PDUFA date; Belite Bio completes rolling NDA submission for tinlarebant in Stargardt disease.
Compass Pathways reports six-month data from its second Phase III COMP006 trial of COMP360 psilocybin for treatment-resistant depression, showing 39% of patients achieved clinically meaningful response maintained through 26 weeks. NDA submission expected in Q4 2026.
Two studies show exercise benefits mental health: one finds exercise programs help smokers quit and reduce cravings for up to 30 minutes; another finds high-intensity exercise outperforms relaxation techniques for panic disorder relief.
Vertex's Phase 3 RAINIER trial of povetacicept in IgA nephropathy met its primary endpoint with a 52% UPCR reduction. The FDA granted rolling review, and Vertex plans full BLA submission by end of March. Shares rose on the news and analyst upgrades.
Novartis acquires UK biotech Myricx Bio for up to $1.5B, gaining a novel NMTi ADC payload platform and two lead assets targeting B7-H3 and HER2. The deal includes $1.1B upfront with $400M in milestones, expected to close in H2 2026.
New court documents link the Project South police corruption probe to alleged Ryan Wedding drug ring associate Gurpreet Singh, while separate U.S. filings accuse "cocaine lawyer" Deepak Paradkar of helping Wedding's organization.
Anthropic announced it will run its own preclinical drug-discovery programs for neglected and rare diseases and launched Claude Science, an AI workbench for researchers. The company has not named specific diseases or detailed how it would bring candidates to market.
The FDA will allow food makers to claim "no artificial colors" as long as dyes are not petroleum-based, even if products contain titanium dioxide. Health experts warn the labeling deceives consumers, as naturally derived additives like titanium dioxide pose health risks and remain unregulated.
Bayer outlined its 2030 growth strategy at Pharma Media Day 2026, driven by AI partnerships, precision medicine, and a strengthened pipeline. The company aims for mid-single-digit growth from 2027 and 30% margins by 2030.
ASH has published new clinical practice guidelines for frontline and relapsed/refractory ALL management in adolescents and young adults, endorsing pediatric-inspired regimens, asparaginase therapy, and immunotherapy over traditional chemotherapy.
The U.S. five-year cancer survival rate reached 70% in 2025, creating 18.6 million survivors. Health systems are expanding survivorship care using advanced practice providers and investing over $4 billion in oncology infrastructure to meet growing demand.
Two new studies advance Lyme disease research: anti-lipid antibodies may enable earlier diagnosis and detect persistent symptoms, while cell wall changes in Borrelia burgdorferi offer insights into Lyme arthritis pathogenesis and potential treatment targets.
Unicycive Therapeutics received an FDA Complete Response Letter for its oxylanthanum carbonate NDA resubmission due to third-party manufacturing deficiencies. The FDA raised no efficacy or safety concerns and requested no new data. Labeling discussions are ongoing.
