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Results For "biologics"

463 News Found

FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma
Drug Approval | May 30, 2024

FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma

Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients


Alvotech and Dr. Reddy’s collaborate for commercialization of AVT03 (denosumab)
News | May 27, 2024

Alvotech and Dr. Reddy’s collaborate for commercialization of AVT03 (denosumab)

Dr. Reddy’s gets exclusive commercialization rights in the United States (U.S.) as well as semi-exclusive rights in Europe and United Kingdom (UK)


Biocon posts Q4 FY24 PAT at Rs. 135 Cr
News | May 17, 2024

Biocon posts Q4 FY24 PAT at Rs. 135 Cr

EBITDA for the quarter stood at Rs 964 crore, representing an EBITDA margin of 24%


Moderna update on investigational RSV vaccine
Drug Approval | May 14, 2024

Moderna update on investigational RSV vaccine

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


Lonza reports softer performance in Q1 2024
News | May 14, 2024

Lonza reports softer performance in Q1 2024

Outlook 2024 remains flat CER sales growth and CORE EBITDA margin of high 20s


USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab
Drug Approval | May 08, 2024

USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab

Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor


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


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


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


Croda and AAHI partner to drive innovation in vaccine development
News | April 15, 2024

Croda and AAHI partner to drive innovation in vaccine development

The exclusive agreement between AAHI and Croda includes a collaborative effort in research and development