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Results For "approvaL"

2477 News Found

Merck and Orion announce option providing Merck global exclusive rights to Opevesostat
News | July 02, 2024

Merck and Orion announce option providing Merck global exclusive rights to Opevesostat

An investigational CYP11A1 Inhibitor, for the treatment of metastatic castration-resistant prostate cancer


Briefs: Family Care Hospitals, Laurus Labs and Bafna Pharmaceuticals
News | June 30, 2024

Briefs: Family Care Hospitals, Laurus Labs and Bafna Pharmaceuticals

Laurus Labs receives EIR from USFDA for API facilities


Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU
News | June 28, 2024

Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU

Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission


Shilpa Medicare Bio Analytical unit gets
Drug Approval | June 27, 2024

Shilpa Medicare Bio Analytical unit gets "No Action Indicated" classification from USFDA

This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies


Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer
Drug Approval | June 26, 2024

Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer

Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care


USDA approves Merck Animal Health’s NOBIVAC NXT canine flu H3N2
Drug Approval | June 26, 2024

USDA approves Merck Animal Health’s NOBIVAC NXT canine flu H3N2

Innovative technology represents a breakthrough scientific achievement for highly contagious respiratory disease


EMA approves Biocon Biologics’ new mAbs facility in India
News | June 24, 2024

EMA approves Biocon Biologics’ new mAbs facility in India

Renews GMP certifications for India and Malaysia sites


Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer
News | June 22, 2024

Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer

Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population


Cipla EU to invest an additional € 3 million in Ethris
News | June 19, 2024

Cipla EU to invest an additional € 3 million in Ethris

Cipla had earlier invested € 15 million in Ethris in 2022


FDA approves Lenire device by Neuromod for tinnitus treatment option for US veterans
Medical Device | June 19, 2024

FDA approves Lenire device by Neuromod for tinnitus treatment option for US veterans

Lenire is the first and only bimodal neuromodulation device to be awarded a Federal Supply Schedule (FSS) Contract from the US Government