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
Biogen and Stoke Therapeutics Collaborate on Zorevunersen for Dravet Syndrome Treatment

Biogen Inc.  and Stoke Therapeutics, Inc. announced a collaboration for the development and commercialization of zorevunersen, a potential f...

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
3Z Pharmaceuticals Unveils Groundbreaking Study Supporting Amlodipine as a Novel Non-Stimulant ADHD Therapy

3Z Pharmaceuticals announced the publication of a transformative study in Neuropsychopharmacology, highlighting compelling scientific evidence that positio...

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
Akeso’s Bispecific Antibody AK139 Receives IND Acceptance from NMPA for Clinical Trials in Respiratory and Skin Diseases

 Akeso, Inc.  is pleased to announce the acceptance of its Investigational New Drug (IND) application by the China National Medical Products Admi...

February 14, 2025 | Friday | News
DAAN Biotherapeutics Signs Exclusive Licensing Agreement with LigaChem Biosciences for Novel Tumor-Targeting Antibody

DAAN Biotherapeutics, a leading innovative drug development company specializing in T-cell receptor (TCR)- based therapies, has signed an exclusive licensi...

February 13, 2025 | Thursday | News
Roche Receives FDA Approval for Evrysdi® Tablet for Spinal Muscular Atrophy

 Roche  announced  that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for an Evrysdi® (risdiplam...

February 13, 2025 | Thursday | News
Novartis to Acquire Anthos Therapeutics, Advancing Development of Abelacimab for Stroke and Thrombosis Prevention

Novartis announced that it has entered into an agreement to acquire Anthos Therapeutics, Inc., a Boston-based, privately held, clinical-stage biopharmaceut...

February 12, 2025 | Wednesday | News
GC Biopharma Presents Promising Updates on LSD Pipeline at WORLD Symposium 2025

GC Biopharma, a South Korean biopharmaceutical company, announced that it presented development updates on its LSD (lysosomal storage disorder) pipelines a...

February 11, 2025 | Tuesday | News
CSL’s HEMGENIX® Delivers Long-Term Bleed Protection for Hemophilia B with Four-Year Data from HOPE-B Study

 Global biotechnology leader CSL announced the four-year results from the pivotal HOPE-B study confirming the long-term durability and safety of a one...

February 10, 2025 | Monday | News
AbbVie Wins FDA Nod for EMBLAVEO™, Tackling Antimicrobial-Resistant Infections

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EMBLAVEO™ (aztreonam and avibactam), as the first and only fixed-...

February 10, 2025 | Monday | News
Cencora Expands Sure Supply Program to Strengthen Drug Shortage Resilience

Cencora, a global healthcare company, has significantly expanded the number and type of medications available in its sure supply program, a drug shortage...

February 07, 2025 | Friday | News

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