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Osimertinib-Chemotherapy Combo Shows Major Benefit in High-Risk EGFR/TP53 NSCLC

Mar 28, 2026

The phase III TOP study shows osimertinib plus chemotherapy more than doubles progression-free survival to 34 months versus 15.6 months with osimertinib alone in EGFR/TP53 mutant NSCLC. The combination achieved an 82.9% response rate and represents a new strategy for this high-risk subgroup. Research continues into resistance mechanisms, including cancer-associated fibroblasts' role in promoting osimertinib resistance.

Sac-TMT Shows Significant Survival Benefit in Pretreated EGFR-Mutated NSCLC

Mar 28, 2026

Sacituzumab tirumotecan demonstrated a median overall survival of 20.0 months versus 13.5 months with docetaxel in pretreated EGFR-mutated NSCLC patients. The phase 2 OptiTROP-Lung03 study showed a hazard ratio of 0.63 for overall survival benefit with the TROP2-directed antibody-drug conjugate.

Novartis Receives Multiple Price Target Increases from Analysts

Mar 26, 2026

Morgan Stanley raised its Novartis price target to $170 from $143 with an Overweight rating, while TD Cowen increased its target to $180 from $160 with a Hold rating. Morgan Stanley sees $23 billion in risk-adjusted potential from nine pipeline assets, with additional upside in success scenarios.

Biotech Firms Advance BLA Pathways with Key Clinical Milestones

Mar 25, 2026

Diamyd Medical anticipates March 2026 interim results from its Phase 3 diabetes trial that could support a BLA pathway. Capricor Therapeutics awaits an August 2026 FDA decision on its Duchenne muscular dystrophy treatment BLA. Bicara Therapeutics prepares for Phase 3 study initiation of its oncology candidate toward future BLA submission.

FDA Approves Subcutaneous Amivantamab for EGFR-Mutated NSCLC

Mar 25, 2026

The FDA approved subcutaneous amivantamab for EGFR-mutated NSCLC in December 2025 based on phase 3 PALOMA-3 trial data showing noninferior efficacy with reduced infusion reactions and 5-minute administration time. The formulation decreases infusion-related reactions from 66% to 13% and improves patient convenience and quality of life. Recent MARIPOSA trial updates show amivantamab plus lazertinib extends median overall survival by at least 12 months versus osimertinib monotherapy.

FDA Approves Monthly Dosing for Johnson & Johnson's Rybrevant Faspro in NSCLC

Mar 23, 2026

The FDA has approved a monthly subcutaneous dosing schedule for Johnson & Johnson's Rybrevant Faspro for EGFR-mutated NSCLC, based on PALOMA-2 trial data showing 82-87% response rates. The approval follows the drug's initial biweekly dosing approval in December 2025 and offers reduced administration time and reactions compared to intravenous delivery.

Dizal's Zegfrovy Meets Phase III NSCLC Endpoint as Other Trials Fail

Mar 23, 2026

Dizal's Phase III trial of Zegfrovy for first-line NSCLC with EGFR exon20ins met its primary endpoint, showing improved progression-free survival. Meanwhile, Immutep halted its Phase III eftilagimod alfa trial, and AstraZeneca's LATIFY trial of ceralasertib plus Imfinzi failed to meet its overall survival endpoint.

Finerenone Shows Kidney Benefit in Non-Diabetic CKD in Phase III FIND-CKD Trial

Mar 19, 2026

Bayer's Phase III FIND-CKD trial shows finerenone significantly slows kidney function decline in non-diabetic chronic kidney disease patients. The drug met its primary endpoint with improved eGFR slope over 32 months, marking its fifth consecutive positive Phase III trial. Bayer plans to submit the data to the FDA for label expansion into non-diabetic CKD.

FDA Accepts Imlifidase BLA for Kidney Transplant Desensitization

Mar 06, 2026

The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.