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Results For "BLA"

276 News Found

FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric
Drug Approval | April 14, 2023

FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric

Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression


LogiPharma launches Asian focused summit, coming to Singapore in June 2023
News | April 05, 2023

LogiPharma launches Asian focused summit, coming to Singapore in June 2023

The summit encompasses multiple verticals, spanning from pharmaceuticals, biotech, life sciences, and the Healthcare sector to ensure an unbiased and comprehensive view on the future of the function.


Antibody-drug conjugates gain traction in China oncology market, says GlobalData
News | April 04, 2023

Antibody-drug conjugates gain traction in China oncology market, says GlobalData

China is among the top countries reporting a high number of diagnosed prevalent cases for gastric, breast, and bladder cancers among the 16 major markets


Thermo Fisher Scientific opens cell therapy facility at University of California
News | March 28, 2023

Thermo Fisher Scientific opens cell therapy facility at University of California

The San Francisco facility is part of Thermo Fisher’s global pharma services network of more than 15 locations supporting cell and gene therapies.


Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Drug Approval | February 25, 2023

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma


USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


Asahi Kasei completes construction of microcrystalline cellulose plant
News | February 18, 2023

Asahi Kasei completes construction of microcrystalline cellulose plant

With the new facility, the company underlines its commitment to meet the substantially growing demand for its MCC


Briefs: Biocon, Laurus Labs and Smruthi Organics
Drug Approval | February 13, 2023

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


Need a paradigm shift for popularising ayurveda in India
News | February 07, 2023

Need a paradigm shift for popularising ayurveda in India

For discovery or for standardization, Ayurveda colleges/institutes need to collaborate closely with Phytochemists, Pharmacologists, and Toxicologists from premier institutions


Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe
Drug Approval | January 21, 2023

Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions