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Zacks News
BMY's Opdivo SC Gets EU Nod for Multiple Solid Tumor Indications
by Zacks Equity Research
Bristol Myers' Opdivo SC wins EU approval as the first PD-1 inhibitor for subcutaneous use across multiple solid tumor indications.
CADL Up as FDA Grants RMAT Status to CAN-2409 in Prostate Cancer
by Zacks Equity Research
Candel stock rises as FDA grants RMAT tag to CAN-2409 after phase III success in prostate cancer. BLA submission is planned at the end of 2026.
Is GSK PLC Sponsored ADR (GSK) Outperforming Other Medical Stocks This Year?
by Zacks Equity Research
Here is how GSK (GSK) and Amarin (AMRN) have performed compared to their sector so far this year.
RCKT Stock Tanks on Patient Death in Danon Disease Study
by Zacks Equity Research
Rocket Pharmaceuticals plunges after a patient death in its Danon disease study, prompting a voluntary dosing pause. The FDA puts a clinical hold on the study.
TEVA Begins IND-Enabling Studies on Inflammatory Disease Candidate
by Zacks Equity Research
TEVA starts IND-enabling studies for BD9, a dual-targeting multibody for asthma and eczema. Shares rise on the news.
VSTM Stock Soars 22% in a Month on Ovarian Cancer Combo Drug Approval
by Zacks Equity Research
Verastem Oncology jumps 22% on FDA nod for Avmapki Fakzynja, the first approved KRAS-mutant LGSOC therapy, with strong early data in a pancreatic cancer study.
AZN Gets CHMP Nod for Imfinzi in Muscle-Invasive Bladder Cancer
by Zacks Equity Research
AstraZeneca wins CHMP nod for Imfinzi combo in muscle-invasive bladder cancer, based on data from the phase III NIAGARA study.
GSK Gets CHMP Nod for Blenrep Combos in Multiple Myeloma
by Zacks Equity Research
GSK wins CHMP nod for Blenrep combos in relapsed or refractory multiple myeloma. A decision in the EU is expected in the third quarter of 2025.
SpringWorks Gets CHMP Nod for Mirdametinib in Rare Disease
by Zacks Equity Research
SWTX wins CHMP backing for mirdametinib in NF1-PN. EU nod is expected in the third quarter of 2025.
Bayer Gets CHMP Nod for Eylea 8 mg in the EU for 2 Major Eye Diseases
by Zacks Equity Research
BAYRY's Eylea 8 mg gets CHMP nod in EU, promising 6-month dosing for nAMD and DME with strong 3-year efficacy and safety data.