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Feb 18, 2026
The FDA agreed to review Moderna's mRNA flu vaccine after initially refusing the application, while separately announcing it will drop its longtime requirement for two clinical studies to approve new drugs.
Feb 18, 2026
The Preeclampsia Foundation released a new educational resource to help OB-GYNs navigate predictive and diagnostic biomarker testing for hypertensive disorders of pregnancy, covering FDA-cleared tests from Thermo Fisher Scientific and Roche Diagnostics.
Feb 18, 2026
Rezon Bio's Warsaw-Duchnice facility has received FDA approval for commercial manufacturing of a biosimilar, following previous EMA GMP certification for European markets.
Feb 18, 2026
Moleculin Biotech announced a preliminary blinded composite complete remission rate of 40% in the first 30 subjects of its Phase 2B/3 MIRACLE trial testing Annamycin plus cytarabine for relapsed or refractory acute myeloid leukemia.
Feb 18, 2026
Phase 3b TOGETHER-PsO trial shows concomitant use of ixekizumab and tirzepatide delivered superior skin clearance and weight loss versus monotherapy in adults with moderate-to-severe plaque psoriasis and obesity or overweight.
Feb 18, 2026
Spruce Biosciences completed two Type B meetings with the FDA regarding tralesinidase alfa enzyme replacement therapy for Sanfilippo syndrome type B. The company now anticipates BLA submission in Q4 2026 to accommodate drug product process performance qualification requirements.
Feb 18, 2026
Researchers at Case Western Reserve University developed a method using ultrasound-activated nanobubbles to break down the collagen barriers surrounding solid tumors, enabling better drug delivery and immune cell penetration. The therapy could reach clinical trials within two years.
Feb 18, 2026
Novartis announced positive Phase III RemIND trial results for oral remibrutinib in chronic inducible urticaria, marking the first therapy to meet a Phase III primary endpoint in the condition. The company has submitted a supplemental New Drug Application to the FDA.
Feb 18, 2026
BioArctic reported net revenues of SEK 184.0 M for Q4 2025, driven by Leqembi royalties and Novartis partnership income. Leqembi received multiple regulatory approvals and submissions across global markets during the quarter.
Feb 18, 2026
Novartis announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint for three prevalent CIndU types with significantly higher complete response rates versus placebo at Week 12.
Feb 18, 2026
The FDA has approved an expanded label for Sandoz's aflibercept biosimilar Enzeevu to include multiple retinal indications beyond its original approval for neovascular age-related macular degeneration. The product is expected to launch in the US in Q4 2026.
Feb 18, 2026
Telix Pharmaceuticals submitted a marketing authorization application in Europe for TLX101-Px, a glioma imaging agent, on February 18, 2026. The filing covers major European markets and a U.S. NDA submission will follow.
Feb 17, 2026
The FDA approved Harmony Biosciences' supplemental new drug application for WAKIX (pitolisant) to treat cataplexy in pediatric patients 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
Feb 17, 2026
Pfizer announced positive progression-free survival results from the BREAKWATER trial evaluating Braftovi in combination with cetuximab and Folfiri in previously untreated metastatic colorectal cancer patients with BRAF V600E mutation.
Feb 17, 2026
Cyclerion Therapeutics received positive FDA feedback on its Phase 2 study design for CYC-126, an anesthetic-based therapy with real-time EEG monitoring for treatment-resistant depression, with study initiation planned for second half of 2026.
Feb 17, 2026
TuHURA Biosciences filed an IND application with the FDA for TBS-2025, a VISTA inhibiting antibody, to be studied in combination with a menin inhibitor for treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia.
Feb 18, 2026
The U.S. orphan drug market is projected to exceed $200 billion by 2031, driven by innovation in oncology and genetic disorders. More than 1,400 FDA-designated orphan drugs are in development or marketed, with over 800 currently in clinical trials.
Feb 18, 2026
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
Feb 18, 2026
Compass Pathways reported COMP360 psilocybin met the primary endpoint in its second phase III trial for treatment-resistant depression, demonstrating a statistically significant reduction in depression severity. The company plans to file a New Drug Application in Q4 2025.
Feb 18, 2026
Medtronic announced FDA premarket approval for Infuse bone graft in transforaminal lumbar interbody fusion procedures at one or two levels from L2-S1, making it the only PMA-approved growth factor bone graft for ALIF, OLIF, and TLIF procedures.
