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Feb 12, 2026
Trethera Corporation completed Phase 1 solid tumor dose escalation trial for TRE-515 and received FDA Fast Track designation for prostate cancer and Orphan Drug status for two autoimmune neurologic diseases.
Feb 13, 2026
Arcutis Biotherapeutics is scheduled to report fourth-quarter and full-year 2025 results on Feb. 25, after market close. Investors will focus on sales performance of Zoryve and pipeline updates.
Feb 13, 2026
Moderna reported Q4 revenue of $678 million, beating analyst estimates, while posting a narrower-than-expected loss of $2.11 per share. The results came as the FDA refused to review the company's mRNA flu vaccine application.
Feb 13, 2026
Zydus Lifesciences resolves US patent litigation with Astellas Pharma over generic Mirabegron for $120 million plus per-unit licensing fees through September 2027, enabling continued US marketing.
Feb 13, 2026
The FDA approved pembrolizumab plus paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian cancer based on phase 3 KEYNOTE-B96 trial results showing improved survival outcomes.
Feb 13, 2026
The FDA has approved Novocure's Optune Pax device for locally advanced pancreatic cancer, marking the first new treatment for this patient group in decades. A trial of 571 patients showed a two-month improvement in overall survival when combined with chemotherapy.
Feb 13, 2026
Eli Lilly announced a $2.4 billion acquisition of Orna Therapeutics and multiple partnerships to expand its drug pipeline beyond its blockbuster GLP-1 franchise into cell and genetic therapies.
Feb 13, 2026
CDC and FDA are investigating a multistate outbreak of extensively drug-resistant Salmonella Newport infections linked to Rosabella brand moringa powder capsules, with seven people sickened across seven states and three requiring hospitalization.
Feb 13, 2026
Vistagen reported fiscal Q3 2026 results with $61.8 million in cash as of December 31, 2025, while advancing its PALISADE-4 Phase 3 trial of fasedienol for social anxiety disorder and preparing an IND submission for refisolone in menopause symptoms.
Feb 13, 2026
Ultragenyx will lay off 130 employees as part of restructuring aimed at profitability by 2027. The FDA rejected the company's gene therapy application for Sanfilippo syndrome due to manufacturing concerns.
Feb 13, 2026
The FDA removed black box warnings related to breast cancer, cardiovascular disease and dementia from six hormone replacement therapies for menopausal women, following a comprehensive review of scientific literature.
Dec 30, 2025
Praxis Precision Medicines has submitted new drug applications for ulixacaltamide in essential tremor and relutrigine in rare epilepsies, both granted Breakthrough Therapy Designation. The company reported $926 million in cash as of December 31, 2025.
Feb 13, 2026
AbbVie filed a lawsuit challenging the federal government's decision to include Botox in Medicare's drug price negotiation program, arguing the drug qualifies as a plasma-derived product excluded under the Inflation Reduction Act.
Feb 13, 2026
Merck stock reached a 52-week high at $122.69, rising 46.25% over 12 months and 7.4% in the past month following strong Q4 results and improved long-term pipeline outlook beyond Keytruda's 2028 patent expiration.
Feb 13, 2026
Multiple law firms have filed securities class actions against Inovio Pharmaceuticals after the FDA accepted its INO-3107 BLA for standard rather than accelerated review, following earlier manufacturing delays with the CELLECTRA device.
Feb 13, 2026
Ultragenyx reported Q4 2025 revenues of $207 million, up 25% year-over-year, while announcing a 10% workforce reduction and resubmission of its UX111 gene therapy application following positive long-term clinical data.
Feb 13, 2026
Multiple law firms have filed securities fraud class actions against uniQure N.V. after the FDA reversed its position on the company's AMT-130 Huntington's disease drug candidate, causing shares to plummet 49% in a single day.
Feb 13, 2026
The FDA will review Moderna's mRNA-1010 seasonal influenza vaccine after the company proposed a revised regulatory pathway, setting an August 2026 decision date following an earlier refusal-to-file letter.
Feb 13, 2026
The FDA approved Optune Pax, a wearable Tumor Treating Fields device, for locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel. The approval marks the first new treatment for this indication in nearly 30 years.
Feb 13, 2026
Samsung Bioepis and Regeneron reached a settlement allowing U.S. launch of Opuviz, an aflibercept biosimilar, in January 2027. The agreement resolves a patent dispute that began in late 2023.
