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Jul 10, 2026
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.
Jul 10, 2026
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.
Jul 10, 2026
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.
Jul 09, 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.
Jul 08, 2026
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.
Jul 07, 2026
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.
Jul 07, 2026
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.
Jul 07, 2026
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.
Jul 03, 2026
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.
Jul 03, 2026
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.
Jun 30, 2026
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.
Jun 29, 2026
Actor Eric Dane died of ALS at age 53 in February 2026, less than a year after announcing his diagnosis. Former NFL star Chris Johnson also revealed his ALS diagnosis at age 39. The cases highlight the neurodegenerative disease, which affects about 33,000 people in the U.S. and has no cure.
Jun 29, 2026
A phase 2 clinical trial published in The Lancet Gastroenterology & Hepatology found that dupilumab significantly improved symptoms and biological markers in patients with eosinophilic gastritis, a rare stomach disease with no approved treatments. The DEGAS study involved 41 patients across 11 U.S. centers.
Jun 29, 2026
All 12 Rett syndrome patients treated with Taysha's TSHA-102 gene therapy in the REVEAL Phase 1/2 trial achieved at least one developmental milestone within one year, with functional gains continuing up to 30 months. The company has completed dosing in the Phase 3 portion and expects top-line data and FDA feedback in early 2027.
Jun 25, 2026
MRI-guided brain stimulation achieved 80% response rates for treatment-resistant depression versus 60% with conventional targeting, per a JAMA Psychiatry study. Separately, Barcelona researchers developed an MRI tool to accurately identify rare neurodegenerative tauopathies PSP and CBD, while experts in Paris discussed AI's growing role in predictive psychiatry.
Jun 25, 2026
Otsuka's ADHD drug centanafadine met the primary endpoint in a Phase 3b trial in adults with comorbid anxiety, with results supporting its efficacy ahead of a July 24, 2026 FDA decision. The FDA has granted priority review to the New Drug Application for the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). If approved, centanafadine would be a novel treatment option for ADHD in children, adolescents, and adults.
Jun 25, 2026
Alliance launches Phase III trial for stage I NSCLC immunotherapy; Allarity starts Phase 2 SCLC trial. Phase I NSCLC trial sites consolidate at top U.S. sites, prompting FDA representation concerns.
Jun 25, 2026
Sanofi announces leadership transition with CEO departure and interim appointment, while reporting key regulatory milestones including FDA Breakthrough Therapy designation for venglustat and expanded Dupixent approvals. The company advances an observational RSV study in Australia and outlines strategic initiatives in AI drug discovery and potential consumer healthcare spin-off.
Jun 24, 2026
A phase 3 trial shows that the oral drug enlicitide reduces LDL cholesterol by 60% compared to placebo, according to results published in the New England Journal of Medicine. Sponsored by Merck & Co., the trial involved 2,909 participants with atherosclerosis or at risk. If approved, enlicitide could help lower heart attack and stroke risk.
Jun 24, 2026
HHS launches broad initiative to boost US clinical trials amid global competition with China. FDA introduces real-time clinical trial monitoring and expedited programs. NIH Long COVID trials set to begin enrolling participants in summer 2026.
