Curated news and analysis on clinical trials, drug approvals, and medical research.
Research shows TET2-driven clonal hematopoiesis improves immune checkpoint blockade efficacy in solid tumors, while separate studies identify new immune pathways in childhood brain cancers and mechanisms behind immunotherapy resistance.
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.
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.
The FDA rejected Disc Medicine's bitopertin for erythropoietic protoporphyria, citing uncertainties about clinical benefit despite the drug receiving a priority review voucher. The company will pursue traditional approval with Phase 3 data expected in late 2026.
The FDA issued a Complete Response Letter for bitopertin in erythropoietic protoporphyria, acknowledging the drug lowers PPIX levels but requiring Phase 3 APOLLO trial results to demonstrate clinical benefit before approval.
The FDA issued a Complete Response Letter for Disc Medicine's bitopertin New Drug Application for erythropoietic protoporphyria, requiring results from the ongoing Phase 3 APOLLO study before making an approval decision. Topline data is expected in Q4 2026.
MEDIPOST has submitted an investigational new drug amendment to the FDA to initiate a Phase III trial of its umbilical cord blood-derived mesenchymal stem cell therapy for knee osteoarthritis, with patient enrollment expected in the first half of 2026.
Odisha introduces a biotechnology research fellowship offering Rs 30,000 monthly to 20 PhD scholars annually, while the state budget approves establishment of dedicated biotechnology research centers and an innovation mission.
Bristol-Myers Squibb received orphan drug designation from the FDA on Feb. 13 for a treatment targeting follicular lymphoma, a type of cancer affecting the lymphatic system.
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.
A Philadelphia jury found Johnson & Johnson liable for a woman's ovarian cancer death linked to talc-based baby powder, awarding $250,000 in damages. The verdict marks the first plaintiffs' win in Philadelphia's talc mass tort litigation.
Viking Therapeutics has completed enrollment in its Phase 3 VANQUISH-1 trial for injectable VK2735 and plans to advance oral VK2735 into Phase 3, while also filing an IND for a new amylin agonist program targeting obesity.
Vertex Pharmaceuticals and CRISPR Therapeutics reported $116 million in full-year 2025 sales for gene-editing therapy Casgevy, with 64 patients receiving infusions and patient initiations nearly tripling compared to 2024.
Gallup has discontinued its presidential approval tracking poll after 88 years, ending the longest-running continuous measurement of U.S. presidential opinion that began during Franklin D. Roosevelt's administration. The polling firm will shift focus to research on broader societal issues.
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.
Novartis agrees to sell its 70.68% stake in Indian unit for $159 million to ChrysCapital-led consortium, while parent company shares reach all-time highs with 55% gains over the past year.
Johnson & Johnson shares have climbed 53% over the past year and 15% year-to-date, with RBC Capital and Bank of America raising price targets on the stock amid strong financial performance and 6% revenue growth in 2025.
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.
Charles River Laboratories is scheduled to report Q4 2025 results on Feb. 18, with analysts raising price targets while the company navigates biotech funding pressures and announces new gene therapy collaborations.
Immunic announced an oversubscribed private placement of up to $400 million to complete phase 3 trials of vidofludimus calcium in relapsing multiple sclerosis, initiate a phase 3 program in primary progressive MS, and transition to a commercial organization.
