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...
Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA® (adalimumab-aaty), as an interchangeable biosim...
INVO Fertility, Inc., formerly known as NAYA Biosciences, Inc., a healthcare services fertility company focused on expanding access to advanced treatment t...
argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the U.S. Food a...
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy®...
Shilpa Medicare announces that Shilpa Pharma Lifesciences – a wholly owned subsidiary – has successfully passed a U.S. Food and Drug Admin...
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