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Feb 15, 2026
A securities fraud class action lawsuit has been filed against uniQure N.V. alleging material misstatements about its Huntington's disease gene therapy AMT-130 and FDA approval pathway between September and October 2025.
Feb 15, 2026
Eli Lilly achieved positive outcomes for nearly all R&D key events in 2025, with successful phase 3 trials for cancer drug Jaypirca, next-gen obesity medicine retatrutide, and oral GLP-1 orforglipron, while Alzheimer's drug Kisunla showed cognitive decline benefits.
Feb 15, 2026
MannKind Corporation has enrolled the first pediatric patient in its INHALE-1ST trial evaluating Afrezza inhaled insulin in children with type 1 diabetes. The FDA is reviewing a supplemental Biologics License Application with a decision expected by May 29, 2026.
Feb 15, 2026
Alphamab Oncology dosed the first patient in its Phase III trial of JSKN003, a biparatopic HER2-targeting antibody-drug conjugate, for HER2-positive advanced colorectal cancer on February 14, 2026.
Feb 15, 2026
DelveInsight releases three separate pipeline reports covering metastatic prostate cancer (80+ companies, 85+ drugs), iPSC-derived NK cells (12+ companies, 15+ drugs), and interstitial lung diseases (120+ companies, 120+ drugs), highlighting recent regulatory approvals, trial launches, and emerging therapies.
Feb 14, 2026
Tempus AI partners with Median Technologies to integrate FDA-cleared eyonis LCS lung cancer screening software into its Pixel platform, marking the first US distribution agreement for the diagnostic tool.
Feb 15, 2026
The FDA agreed to review Moderna's mRNA flu vaccine application after initially rejecting it, reversing course within a week. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and above, with a decision expected by August 5.
Feb 15, 2026
Eli Lilly announced a $2.4 billion acquisition of Orna Therapeutics and two additional collaborations totaling over $1 billion to develop treatments for immune disorders, cancer, and hearing loss gene therapies.
Feb 15, 2026
Vaxcyte has initiated its Phase 3 adult program for VAX-31, a 31-valent pneumococcal conjugate vaccine, with the pivotal OPUS-1 trial enrolling 4,000 adults aged 50 and older. The company plans to submit a Biologics License Application by the end of next year.
Feb 15, 2026
Nuvalent provided updates on regulatory milestones for its lead oncology programs, including FDA acceptance of the zidesamtinib NDA with a September PDUFA date and plans to submit an NVL-655 NDA in the first half of 2026.
Feb 15, 2026
The FDA will consider revoking safety exemptions for ultra-processed foods including corn syrup, while retatrutide, a triple-receptor weight loss drug, advances through phase three clinical trials without yet receiving regulatory approval.
Feb 14, 2026
Novo Nordisk confronts rising generic threats to its semaglutide-based drugs while navigating FDA scrutiny and legal challenges. The company advances oral semaglutide into pediatric diabetes care as competitors prepare to launch imitations.
Feb 14, 2026
Eli Lilly achieved positive outcomes for nearly all R&D key events in 2025 and acquired Orna Therapeutics for $2.4 billion to develop circular RNA therapies for autoimmune diseases.
Feb 14, 2026
The CDC is investigating a multistate outbreak of extensively drug-resistant Salmonella Newport with an NDM-1 gene linked to Rosabella moringa powder capsules, marking the first documented outbreak of Salmonella with an NDM-1 gene in the United States.
Feb 14, 2026
Disc Medicine received a complete response letter from the FDA for bitopertin as a treatment for erythropoietic protoporphyria. The FDA acknowledged the drug lowers PPIX levels but requires evidence from the ongoing Phase 3 APOLLO study before approval.
Feb 14, 2026
Researchers have developed modified CAR T cells that overcome prostaglandin E2 suppression in solid tumors and a selective therapy targeting IGHV4-34 that spares healthy immune cells, addressing key limitations in current treatments.
Feb 14, 2026
Ocular Therapeutix announced positive topline results from SOL-1, its Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting primary and durability endpoints with high statistical significance.
Feb 14, 2026
Ultragenyx Pharmaceutical announced positive long-term clinical data for UX111 gene therapy for Sanfilippo syndrome Type A, with up to 8.5 years of follow-up showing sustained biomarker reductions and functional improvements. The company resubmitted its BLA to the FDA in January 2026.
Feb 14, 2026
Moderna challenges FDA's refusal to review its mRNA flu vaccine application, citing shifting regulatory expectations. The company reported Q4 revenue of $678 million as COVID vaccine uptake fell 26% in 2025.
Feb 14, 2026
Eli Lilly acquired Orna Therapeutics for $2.4 billion and announced multiple partnerships while investing in AI drug discovery infrastructure, including building the industry's largest AI supercomputer to boost clinical trial success rates.
