Related coverage linked through entity extraction aliases.
Feb 26, 2026
The FDA cleared NexEos Bio's IND application to proceed with a Phase II/III trial of NTX-1024 ophthalmic solution for vernal keratoconjunctivitis, following positive results from a 15-patient study in Mexico.
Feb 26, 2026
Crinetics Pharmaceuticals reported over $5 million in preliminary net product revenue for PALSONIFY in Q4 2025, while Phase 2 data for its congenital adrenal hyperplasia treatment showed promising results that analysts say have derisked the Phase 3 study design.
Feb 26, 2026
New combination therapies demonstrate improved outcomes in advanced anal and colorectal cancers, with retifanlimab plus chemotherapy approved for anal cancer and onvansertib showing strong efficacy signals in RAS-mutated colorectal cancer.
Feb 26, 2026
Edgewise Therapeutics and IDEAYA Biosciences released annual financial reports detailing clinical trial progress and strategic initiatives. Both companies are advancing multiple clinical-stage programs while managing significant operating expenses.
Feb 26, 2026
New analysis suggests leptin hormone could normalize blood sugar in type 1 diabetes by acting on the brain, potentially offering an alternative to daily insulin injections based on research dating back to 2011.
Feb 25, 2026
Palvella Therapeutics announced positive topline results from its Phase 3 SELVA study of QTORIN 3.9% rapamycin for microcystic lymphatic malformations, meeting all primary and secondary endpoints with strong tolerability. The company plans an NDA submission in H2 2026.
Feb 26, 2026
Health and Human Services Secretary Robert F. Kennedy Jr. announced plans to review the safety of ultra-processed foods, criticizing the GRAS exemption that allows companies to verify ingredient safety without FDA oversight since 1997.
Feb 25, 2026
Gilead Sciences will acquire Arcellx for $7.8 billion to expand their CAR-T cell therapy collaboration. The deal includes $115 per share at closing plus contingent payments based on sales milestones.
Feb 23, 2026
The FDA has filed Savara's biologics license application for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a target action date of August 22, 2026.
Feb 25, 2026
The FDA approved BYSANTI (milsaperidone) for bipolar I disorder and schizophrenia in adults, and accepted Vanda's BLA filing for imsidolimab to treat Generalized Pustular Psoriasis with a target action date of December 12, 2026.
Feb 21, 2026
The FDA has accepted Teva Pharmaceuticals' New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine injection for treating schizophrenia in adults, based on Phase 3 trial data showing efficacy consistent with existing formulations without requiring post-injection monitoring.
Feb 21, 2026
The FDA has accepted Dr. Reddy's Laboratories' BLA for DRL_AB, a proposed interchangeable biosimilar to abatacept, submitted in December 2025. The application is the first for an abatacept biosimilar and is supported by Phase 1 data showing pharmacokinetic similarity.
Feb 22, 2026
NanoViricides is preparing to advance NV-387 into a Phase II clinical trial for Monkeypox in the Democratic Republic of Congo, with regulatory approval received and full funding secured through recent financings totaling approximately $6.2 million.
Feb 25, 2026
Axogen reported Q4 2025 revenue of $59.9 million, up 21.3% year-over-year, but swung to a net loss due to FDA BLA approval costs. The company secured 12 years of market exclusivity for Avance Nerve Graft and guided 2026 revenue growth of at least 18%.
Feb 24, 2026
The FDA has granted fast track designation to ART6043 plus olaparib for germline BRCA-mutated HER2-negative breast cancer and to BriaCell's Bria-IMT plus immune checkpoint inhibitor for metastatic breast cancer, both addressing significant unmet medical needs.
Feb 21, 2026
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
Feb 24, 2026
Lupin Limited reported strong Q3 FY26 results with total sales of ₹71,005 million, up 26% year-over-year, and received US FDA approval for its pegfilgrastim biosimilar Armlupeg™, which has not yet been launched.
Feb 21, 2026
The controversy over direct-to-consumer prescription drug advertising has gained renewed attention from the Trump administration and legislators, with spending reaching $9 billion in 2024 and debate centering on whether such ads benefit or harm consumers.
Feb 20, 2026
Phase III SMART trial data show clesrovimab maintained consistent safety and efficacy in high-risk children across two RSV seasons, with no drug-related serious adverse events reported in either season.
Feb 21, 2026
The FDA has approved a once-monthly dosing schedule for subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) combined with lazertinib for first-line treatment of EGFR-mutated advanced NSCLC, based on PALOMA-2 trial data showing comparable efficacy to biweekly dosing.
