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Feb 20, 2026
PureTech Health announced that deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for idiopathic pulmonary fibrosis, with a Phase 3 trial planned for the first half of 2026.
Feb 20, 2026
PureTech Health's deupirfenidone has received Orphan Drug Designation from both the U.S. FDA and European Commission for treating idiopathic pulmonary fibrosis, a rare and fatal lung disease. Phase 2b trial results showed superior efficacy compared to existing therapies.
Feb 20, 2026
The U.S. Court of Appeals for the Federal Circuit ruled that Teva Pharmaceuticals did not infringe Corcept Therapeutics' patents for methods of safely co-administering Korlym with CYP3A4 inhibitors, affirming a 2023 district court verdict.
Feb 19, 2026
Serina Therapeutics has enrolled the first patient in its Phase 1b registrational trial evaluating SER-252 in patients with advanced Parkinson's disease in Australia, with dosing expected to begin in the first quarter of 2026.
Feb 19, 2026
Vie Ventures, a life sciences venture capital firm focused on autoimmune and immune-mediated diseases, announced that Jeff Bluestone, PhD, has been named Managing Director, joining founders Steven St. Peter, MD, and Luke Evnin, PhD.
Feb 19, 2026
The FDA has accepted for Priority Review the Biologics License Application for garetosmab to treat adults with fibrodysplasia ossificans progressiva, with a target decision date of August 2026. The application is supported by Phase 3 OPTIMA trial data showing significant reductions in heterotopic bone lesions.
Feb 19, 2026
Online telehealth company Hims & Hers withdrew plans to offer a $49 compounded oral semaglutide pill after FDA Commissioner Marty Makary called such products "illegal copycats" and Novo Nordisk filed a patent infringement lawsuit.
Feb 19, 2026
Phase 3 LATITUDE trial shows monthly cabotegravir-rilpivirine injections cut regimen failure risk by 18.4 percentage points compared to daily oral ART in HIV patients with documented adherence difficulties.
Feb 19, 2026
National Institutes of Health Director Jay Bhattacharya will serve as acting director of the Centers for Disease Control and Prevention following Jim O'Neill's departure. Bhattacharya will oversee both agencies simultaneously as the CDC faces significant instability.
Feb 19, 2026
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-1010 seasonal influenza vaccine application, setting an August 5, 2026 review deadline after the company proposed a revised regulatory approach based on age groups.
Feb 19, 2026
Researchers at Washington University in St. Louis have adapted CAR-T immunotherapy to target aggregated amyloid-beta in mice, with transient CAR expression clearing brain plaques. The approach uses CD4+ T cells engineered with receptors based on lecanemab antibody sequences.
Feb 19, 2026
ImmunityBio has partnered with Accord Healthcare to expand access to Anktiva across 30 countries following conditional EU authorization. The company established an Irish subsidiary to support European distribution and commercialization.
Feb 18, 2026
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-based flu vaccine application, with a decision expected by August 5. The company modified its regulatory approach to address concerns about older adults.
Feb 19, 2026
The FDA will host Rare Disease Day 2026 on February 23, focusing on patient engagement and accelerating treatment development. The agency released its 2026 Strategic Agenda for the Rare Disease Hub, outlining new regulatory pathways and coordination efforts.
Feb 18, 2026
FDA Commissioner Marty Makary outlined plans to expand over-the-counter drug access, crack down on unlawful GLP-1 compounding, and address the U.S. falling behind China in early-stage drug development.
Feb 18, 2026
A University of South Australia study finds salcaprozate sodium (SNAC), the compound enabling oral semaglutide tablets to work, may alter gut bacteria and increase inflammatory markers in rats, though human effects remain unclear.
Feb 18, 2026
Dr. Reddy's Laboratories is poised to launch generic oral and injectable semaglutide in India following regulatory approval, targeting a market projected to exceed $1 billion driven by 100 million diabetics.
Feb 18, 2026
The U.S. FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as monotherapy for adults with advanced head and neck squamous cell carcinoma, based on Phase 1b/2 study data showing rapid and durable responses.
Feb 20, 2026
BioNTech filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging that Moderna's next-generation COVID-19 vaccine mNEXSPIKE violates its mRNA vaccine design patent.
Feb 18, 2026
The FDA has expanded a recall of raw oysters from Stellar Bay Shellfish due to norovirus contamination and issued a nationwide recall of Tippy Toes baby food fruit puree due to elevated patulin levels.
