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1749 News Found

Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL
Drug Approval | July 15, 2025

Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL

Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments


FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%
Drug Approval | July 15, 2025

FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,


Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
News | July 15, 2025

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025


FDA accepts new drug application for Merck’s Doravirine/Islatravir
Drug Approval | July 11, 2025

FDA accepts new drug application for Merck’s Doravirine/Islatravir

The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act


Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting
News | July 11, 2025

Pfizer and Astellas' Xtandi combo extends survival in early prostate cancer setting

Xtandi is approved in over 80 countries, including the U.S., EU, and Japan


BioMed X and Servier launch AI-powered antibody research at New XSeed Labs in Paris-Saclay
News | July 09, 2025

BioMed X and Servier launch AI-powered antibody research at New XSeed Labs in Paris-Saclay

The first project will focus on developing an AI-based platform for the sterically guided design of bispecific antibodies


OneSource Specialty Pharma appoints Jeffrey Wong as CBO
People | July 08, 2025

OneSource Specialty Pharma appoints Jeffrey Wong as CBO

He has held senior leadership positions at Syngene International, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Sartorius Stedim Biotech, and other leading organizations


Duke Street Bio receives FDA fast track designation for PARP1-selective inhibitor with CNS activity
Biotech | July 08, 2025

Duke Street Bio receives FDA fast track designation for PARP1-selective inhibitor with CNS activity

Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need


AB Science receives FDA and EMA authorization for phase 3 Trial of prostate cancer treatment
Clinical Trials | July 08, 2025

AB Science receives FDA and EMA authorization for phase 3 Trial of prostate cancer treatment

Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments


Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars
News | July 07, 2025

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone