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924 News Found

USFDA approves intramuscular administration for Merck’s MMRV family of vaccines
Drug Approval | March 07, 2023

USFDA approves intramuscular administration for Merck’s MMRV family of vaccines

With this additional route of administration, the MMRV Family now joins other routinely recommended vaccines that can be administered intramuscularly


Aster DM Healthcare appoints Purana H Deepti as Additional Director
People | March 06, 2023

Aster DM Healthcare appoints Purana H Deepti as Additional Director

She was the CEO of Tata Insights and Quants a Division of the Tata Industries Ltd.


Merck and AstraZeneca updates on US regulatory review of Lynparza for mCRPC
News | March 03, 2023

Merck and AstraZeneca updates on US regulatory review of Lynparza for mCRPC

AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.


EMA recommends refusal of the marketing authorization for Lagevrio
News | February 25, 2023

EMA recommends refusal of the marketing authorization for Lagevrio

Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.


Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Drug Approval | February 25, 2023

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.


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


Merck and AstraZeneca present final results from Phase 3 PROpel Trial
Drug Approval | February 18, 2023

Merck and AstraZeneca present final results from Phase 3 PROpel Trial

Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival


CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer
Drug Approval | January 31, 2023

CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer

CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5%


Alkem to launch novel antibiotic for MDR infections
News | January 31, 2023

Alkem to launch novel antibiotic for MDR infections

Zidavi is recommended by the Infectious Disease Society of America