Johnson & Johnson Reports Positive Phase 3 ASTRO Study Data for TREMFYA® in Adults with Moderately to Severely Active Ulcerative Colitis

Johnson & Johnson announced data from the Phase 3 ASTRO study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with...

February 24, 2025 | Monday | News
Chime Biologics Advances MG-K10, Novel IL-4Rα Antibody, into U.S. Phase III Trials with Mabgeek

Chime Biologics, a leading global CDMO that enables its partners success in biologics, announced its continued collaboration with Mabgeek in adva...

February 24, 2025 | Monday | News
Novo Nordisk Announces FDA Resolution of Wegovy® and Ozempic® Supply Shortage in the U.S.

Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has determined the shortage of Wegovy® and Ozempic® is resolved. ...

February 24, 2025 | Monday | News
Ionis Pharmaceuticals to Present New Data on Donidalorsen for Hereditary Angioedema at AAAAI/WAO Joint Congress

Ionis Pharmaceuticals, Inc.  announced that it will present additional data from the pivotal Phase 3 OASIS and OASISplus studies, as well as three yea...

February 21, 2025 | Friday | News
Phanes Therapeutics Doses First Patient in Clinical Trial of Peluntamig (PT217) for Advanced Cancers

Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced that the f...

February 20, 2025 | Thursday | News
Merilog Receives FDA Approval as the First Rapid-Acting Insulin Biosimilar

The U.S. Food and Drug Administration (FDA) approved Merilog (insulin aspart szij) as a Novolog biosimilar to (insulin aspart) to improve glycemi...

February 20, 2025 | Thursday | News
Ultragenyx Announces FDA Acceptance of BLA for UX111 Gene Therapy to Treat Sanfilippo Syndrome Type A

Ultragenyx Pharmaceutical Inc. announced the U.S. Food and Drug Administration (FDA or the Agency) has accepted for review the Biologics License Applicatio...

February 19, 2025 | Wednesday | News
Gilead Sciences Announces FDA Acceptance of NDA for Lenacapavir as Twice-Yearly HIV Prevention Treatment

Gilead Sciences, Inc.  announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapa...

February 19, 2025 | Wednesday | News
Sanofi and Regeneron’s Dupixent Gains FDA Priority Review for Bullous Pemphigoid Treatment

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) t...

February 19, 2025 | Wednesday | News
Navi Medical Technologies' Neonav® ECG Tip Location System Receives FDA 510(k) Clearance for Pediatric Care

Navi Medical Technologies, a medical device company focused on pediatric healthcare innovation, proudly announces that its Neonav® ECG Tip Location Sys...

February 18, 2025 | Tuesday | News
Rznomics’ RZ-001 Receives Fast Track Designation from FDA for Hepatocellular Carcinoma Treatment

Rznomics announced on the 14th that its anticancer drug, RZ-001, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for t...

February 18, 2025 | Tuesday | News
TAHO Pharmaceuticals Announces Positive Preliminary Results for TAH3311, World’s First Oral Resolution Film of Apixaban

TAHO Pharmaceuticals announces positive preliminary results from the pivotal study of TAH3311, the world's first oral resolution film (ODF) of apixaban. Th...

February 18, 2025 | Tuesday | News
GSK Receives FDA Approval for Penmenvy, a Pentavalent Meningococcal Vaccine for Adolescents and Young Adults

GSK plc announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use i...

February 17, 2025 | Monday | News
Theratechnologies Resumes Distribution of EGRIFTA SV® Following FDA Approval to Release Manufactured Batches

Theratechnologies Inc., a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine ...

February 14, 2025 | Friday | News

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