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Feb 27, 2026
Phase 2 trial of amivantamab in recurrent/metastatic adenoid cystic carcinoma achieved 72.2% clinical benefit rate with good tolerability. Combination therapy with pembrolizumab is being evaluated in head and neck squamous cell cancer.
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 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.
Feb 25, 2026
The FDA has approved a new monthly dosing schedule for Johnson & Johnson's Rybrevant Faspro combined with Lazcluze for first-line treatment of advanced EGFR-mutated non-small cell lung cancer, allowing patients to transition to monthly dosing as early as week five.
Feb 25, 2026
Phase 3 trials demonstrate atrasentan slows kidney function decline in IgA nephropathy patients, while obinutuzumab achieves superior remission rates in primary membranous nephropathy compared to standard treatment.
Feb 24, 2026
Vir Biotechnology reported Q4 EPS of ($0.31), beating estimates by $0.23, with revenue of $64.07 million. The company announced a global strategic collaboration with Astellas for VIR-5500 and reported $781.6 million in cash and investments.
Feb 24, 2026
Vir Biotechnology announced a global strategic collaboration with Astellas for VIR-5500, a PSMA-targeted dual-masked T-cell engager for prostate cancer, and reported $781.6 million in cash and investments as of December 31, 2025.
Feb 19, 2026
Novartis commits $23 billion to U.S. manufacturing expansion with new facilities in North Carolina, California, and Florida, while advancing its immunoglobulin A nephropathy drug portfolio with positive Phase III results for Vanrafia.
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 19, 2026
Hansa Biopharma announced on February 18, 2026 that the FDA has accepted its Biologics License Application for imlifidase, supported by positive Phase 3 ConfIdeS trial results in highly sensitized kidney transplant patients.
Feb 17, 2026
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.
Feb 16, 2026
Eli Lilly's Retevmo (selpercatinib) demonstrated statistically significant event-free survival improvement in the Phase III LIBRETTO-432 trial for early-stage RET fusion-positive non-small cell lung cancer.
Feb 16, 2026
Eli Lilly announced positive Phase 3 LIBRETTO-432 trial results showing Retevmo (selpercatinib) significantly improved event-free survival in patients with early-stage RET fusion-positive non-small cell lung cancer as adjuvant therapy.
Feb 16, 2026
Novartis announced final Phase III ALIGN trial results showing Vanrafia (atrasentan) slowed kidney function decline in adults with IgA nephropathy, with a 2.39ml/min/1.73m² eGFR difference versus placebo at week 136.
Feb 14, 2026
A newly published study in Int. J. Mol. Sci. confirms that deuterium concentration directly influences gene expression in lung adenocarcinoma cells, validating HYD LLC's three-decade research on deuterium-depleted water as a complementary cancer therapy.
Feb 13, 2026
Real-world study finds SGLT2 inhibitors reduce chronic kidney disease and acute kidney injury risk more effectively than GLP-1 receptor agonists in patients with type 2 diabetes, with greatest benefits in those without preexisting kidney disease.
May 01, 2025
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
Dec 18, 2025
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.
Feb 13, 2026
Novartis announced final Phase III ALIGN results showing Vanrafia slowed kidney function decline in adults with IgA nephropathy, supporting planned submissions for traditional approval in 2026 following accelerated approvals in the U.S. and China in 2025.
