Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer
Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV
Sales reflect continued strong growth in oncology and vaccines
Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market
Submission based on results from pivotal phase III trial showing all primary endpoints met
Versavo is the first Dr. Reddy's biosimilar product to be approved and launched in the UK
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
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