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Results For "phase-3"

686 News Found

Palatin completes sale of Vyleesi to Cosette Pharmaceuticals for up to $171 mn
News | January 02, 2024

Palatin completes sale of Vyleesi to Cosette Pharmaceuticals for up to $171 mn

Vyleesi is the first and only as-needed treatment approved by the Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD)


Lyndra Therapeutics raises US$101 million in Series E funding
News | December 25, 2023

Lyndra Therapeutics raises US$101 million in Series E funding

Funding round led by Sarissa Capital, includes Sun Pharma, Polaris Partners


FDA grants priority review to Merck’s new biologics license application for V116
Drug Approval | December 20, 2023

FDA grants priority review to Merck’s new biologics license application for V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults


FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B
Drug Approval | December 13, 2023

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting


FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric
Drug Approval | November 17, 2023

FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric

Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone


Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting
Drug Approval | November 17, 2023

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer


Sanofi completes closing for potential first-in-class vaccine against ExPEC
News | November 16, 2023

Sanofi completes closing for potential first-in-class vaccine against ExPEC

Extraintestinal pathogenic E. coli (ExPEC) has been identified as the leading bacterial cause of sepsis


Teva, Royalty Pharma collaborate to further accelerate Olanzapine LAI program
Clinical Trials | November 15, 2023

Teva, Royalty Pharma collaborate to further accelerate Olanzapine LAI program

Phase 3 data expected in the second half of 2024


Glenmark Pharma reports Q2 FY24 loss at Rs. 62 Cr
News | November 13, 2023

Glenmark Pharma reports Q2 FY24 loss at Rs. 62 Cr

European operations' revenue grew 58.4% to Rs 599.7 crore