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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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Qfitlia Approved as First US Therapy for Hemophilia A/B with or without Inhibitors
The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of…
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Imfinzi Approved as First Perioperative Immunotherapy for Bladder Cancer
AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery…
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Lexicon Pharmaceuticals Signs Exclusive License Agreement with Novo Nordisk for LX9851
Lexicon Pharmaceuticals, Inc. announced that it has entered into an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development…
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Ionis Expands Partnership with Sobi for Olezarsen Commercialization Outside the U.S.
Ionis Pharmaceuticals, Inc. announced that it has entered into a license agreement under which Sobi receives exclusive rights in countries outside the U.S., Canada and China to…
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European Commission Approves Merck’s CAPVAXIVE for Pneumococcal Disease in Adults
Merck, known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for active…
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FDA Grants Fast Track to Chlamydia Vaccine Candidate
The US Food and Drug Administration has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia infection. The decision was based on the…
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United Laboratories & Novo Nordisk Announce Exclusive License for UBT251
The United Laboratories International Holdings Limited (TUL) and Novo Nordisk A/S (Novo Nordisk) announced that Novo Nordisk and TUL’s wholly-owned subsidiary The United Bio-Technology…
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FDA Approves Blujepa for Uncomplicated UTIs in Women and Kids 12+
GSK plc announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40…
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Novartis Gains FDA Approval for Fabhalta in C3G
Novartis today announced that oral Fabhalta (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce…
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Oxford BioTherapeutics Partners with Roche on Cancer Targets
Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology (IO) and Antibody Drug Conjugate (ADC)-based therapies, announced a multi-year…
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