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Trixeo Aerosphere Approved in UK as First Inhaled Respiratory Drug with Near-Zero GWP Propellant
AstraZeneca’s inhaled medicine Trixeo Aerosphere has become the first pressurised metered-dose inhaler (pMDI) to be approved in the UK using a next-generation propellant with near-zero…
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Novo Nordisk’s Once-Weekly Sogroya Proves Effective in Children with Growth Disorders
Novo Nordisk presented data from the phase 3 REAL8 basket study, which showed that once-weekly Sogroya (somapacitan) was non-inferior to the once-daily growth hormone Norditropin…
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Amneal and ApiJect Partner to Boost U.S. Sterile BFS Manufacturing Capacity
Amneal Pharmaceuticals, Inc. and Apiject Systems, Corp. announced a strategic collaboration to expand domestic production of Apiject’s BFS-based injectable platform at Amneal’s…
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Oral Semaglutide 25 mg Filing Accepted by FDA; Could Be First Oral GLP-1 for Obesity
Novo Nordisk has announced that the FDA has accepted the New Drug Application (NDA) for a once-daily 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in…
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Teva and Alvotech Gain FDA Interchangeability for SELARSDI Biosimilar to Stelara
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI™…
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QIAGEN Expands Digital PCR Portfolio with New Lentivirus Solutions
QIAGEN announced the expansion of its cell and gene therapy (CGT) portfolio with enhanced digital PCR (dPCR) solutions tailored for lentivirus-based applications. These solutions are…
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Oxford, Boehringer, Cumulus Launch First-Ever Study on Daily Life with Psychiatric Disorders
Boehringer Ingelheim, the University of Oxford, and Cumulus Neuroscience are joining forces to provide insights into the day-to-day experiences of people living with psychiatric…
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Merck Breaks Ground on $1B Biologics Center in Delaware
Merck, known as MSD outside the U.S. and Canada, has announced the start of construction on a $1 billion, 470,000-square-foot Biologics Center of Excellence in Wilmington, Delaware.…
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Regeneron Invests in Expanding Biologic Medicine Manufacturing
Regeneron Pharmaceuticals, Inc. announced a significant expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotechnologies (“Fujifilm”) to…
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Boehringer Ingelheim and Tessellate Bio Partner on Precision Treatments for Hard-to-Treat Cancers
Boehringer Ingelheim and Tessellate Bio, a precision oncology company with a focus on developing novel synthetic lethality approaches, have entered into a research collaboration and…
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Roche to Invest $50B in U.S. Pharma and Diagnostics Over 5 Years
Roche announced that it will invest USD 50 billion into the United States of America in the next five years. These investments further strengthen Roche’s already significant US…
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uniQure’s AMT-130 Gets FDA Breakthrough Tag for Huntington’s
uniQure N.V. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AMT-130 for the treatment of Huntington’s disease, a rare,…
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Dupixent Approved in U.S. as First Targeted Therapy in Over a Decade for Chronic Hives
The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU)…
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Boehringer Ingelheim and Cue Biopharma Team Up on Next-Gen Autoimmune Therapies
Boehringer Ingelheim and Cue Biopharma, Inc. announced a strategic research collaboration and license agreement to develop and commercialize Cue Biopharma’s CUE-501 product candidate, a…
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EU Approves Roche’s Columvi as First Bispecific Antibody for DLBCL After Initial Treatment
Roche announced that the European Commission has approved Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of adult patients with relapsed…
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Bristol Myers Squibb Shares Phase 3 ODYSSEY-HCM Trial Update
Bristol Myers Squibb announced the Phase 3 ODYSSEY-HCM trial evaluating Camzyos (mavacamten) for the treatment of adult patients with symptomatic New York Heart Association (NYHA) class…
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argenx Wins FDA Approval for VYVGART Hytrulo Self-Injection
argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA)…
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UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD).…
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Rilzabrutinib Receives Orphan Drug Designation for Two Rare Diseases
The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible Bruton’s tyrosine kinase (BTK)…
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Amneal Launches BORUZU, First Ready-to-Use Bortezomib Injection
Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited announced the U.S. launch of BORUZU, a new presentation of bortezomib for ready-to-use subcutaneous administration or…
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