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Results For "BLA"

301 News Found

FDA grants full approval for TIVDAK to treat cervical cancer
Drug Approval | May 02, 2024

FDA grants full approval for TIVDAK to treat cervical cancer

TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer


FDA approves Biktarvy label update with data for pregnant adults with HIV
Drug Approval | April 27, 2024

FDA approves Biktarvy label update with data for pregnant adults with HIV

Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV


Merck 1Q 2024 sales up 9% to US$ 15.8 billion
News | April 26, 2024

Merck 1Q 2024 sales up 9% to US$ 15.8 billion

Sales reflect continued strong growth in oncology and vaccines


Zydus launches Mirabegron ER Tablets in the US
Drug Approval | April 22, 2024

Zydus launches Mirabegron ER Tablets in the US

Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market


GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
Drug Approval | April 17, 2024

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met


Dr. Reddy's Laboratories launches Versavo in the UK
News | March 19, 2024

Dr. Reddy's Laboratories launches Versavo in the UK

Versavo is the first Dr. Reddy's biosimilar product to be approved and launched in the UK


Biocon Biologics secures US market entry date for Bmab 1200
Drug Approval | March 01, 2024

Biocon Biologics secures US market entry date for Bmab 1200

The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA


Moderna posts Q4 2023 revenue at US$ 2.8 billion
News | February 23, 2024

Moderna posts Q4 2023 revenue at US$ 2.8 billion

Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance


Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Drug Approval | January 31, 2024

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis


Kokilaben Dhirubhai Ambani Hospital introduces revolutionary HIFU Technology for prostate cancer treatment
Hospitals | January 10, 2024

Kokilaben Dhirubhai Ambani Hospital introduces revolutionary HIFU Technology for prostate cancer treatment

HIFU is a state-of-the-art treatment that utilizes high-frequency sound waves to target and destroy prostate cancer cells