U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produc...
Invivyd, Inc. announced it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) calling on the Agency to evolve from histori...
UTR Therapeutics Inc (UTRx Inc.), a drug development biotech company based in New York City, USA is pleased to announce a new milestone, the submission o...
Shuttle Pharmaceuticals Holdings, Inc. , a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer pati...
Complementary nature of these two immunotherapies leads to excellent 17.6-month median Overall Survival in head and neck cancer patients with PD-L1 CPS...
The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentat...
IgA nephropathy (IgAN) is an autoimmune disorder that affects the kidneys by impairing the filtration function of the small blood vessels. It is caused by ...
From April 25 to April 30, 2025, U.S. time, ImmVira presented the Phase I clinical results of its oncolytic Herpes Simplex Virus ("oHSV") product MVR-...
Ascletis Pharma Inc. announces positive topline results of its randomized, double-blind, placebo-controlled Phase Ib multiple ascending d...
Regeneron Pharmaceuticals, Inc. announced a significant expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotec...
Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo In the US, there are more than 300,0...
DESTINY-Breast09 phase 3 trial of Daiichi Sankyo and AstraZeneca’s ENHERTU is the first trial in more than a decade to demonstrate superior eff...
Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding ...
Pfizer Inc. announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) vote...
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