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Results For "European-Union"

187 News Found

Lilly's Lebrikizumab shows improved face or hand dermatitis
Diagnostic Center | May 02, 2023

Lilly's Lebrikizumab shows improved face or hand dermatitis

Lebrikizumab is an investigational high-affinity and potent IL-13 inhibitor being studied in adult and adolescent patients


Getinge to boost scalability and deepen healthcare access in India
Medical Device | April 01, 2023

Getinge to boost scalability and deepen healthcare access in India

Getinge has a strong market share in India within several product segments


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


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.


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%


Pfizer expands ‘An Accord for a Healthier World’ product offering in 45 lower-income countries
Healthcare | January 23, 2023

Pfizer expands ‘An Accord for a Healthier World’ product offering in 45 lower-income countries

Products offered on a not-for-profit basis to the 45 lower-income countries now include the full portfolio for which Pfizer has global rights.


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