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Datroway Approved in U.S. for Advanced EGFR-Mutated Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Datroway (datopotamab deruxtecan or Dato-DXd) for the treatment of adult patients with locally advanced…
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argenx Wins EU Approval for VYVGART SC to Treat CIDP
argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the European Commission (EC) approved VYVGART…
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Yeztugo Becomes First FDA-Approved HIV Prevention with 6-Month Protection
Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo (lenacapavir) as a pre-exposure prophylaxis (PrEP) to prevent sexually acquired HIV-1.…
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J&J Seeks FDA Approval of STELARA for Pediatric Crohn’s Disease
Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand approval of…
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Lilly to Acquire Verve Therapeutics for One-Time Cardiovascular Treatments
Eli Lilly and Company and Verve Therapeutics, Inc., a Boston-based clinical-stage company developing genetic medicines for cardiovascular disease, announced a definitive agreement for…
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Teva and Fosun Partner to Develop Novel Anti-PD1-IL2 Cancer Therapy
Teva Pharmaceutical Industries Ltd. and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that the companies, through their respective subsidiaries, have entered a strategic…
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BioNTech to Acquire CureVac in Strategic Public Exchange Deal
BioNTech SE and CureVac N.V. announced that they have entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all of the shares of CureVac, a…
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FDA Approves MAVYRET as First Treatment for Acute Hepatitis C
AbbVie announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for MAVYRET (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA)…
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FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants
Merck, known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has approved ENFLONSIA™ (clesrovimab-cfor) for the prevention of…
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EU Approves Roche’s Evrysdi as First Oral Treatment for SMA
Roche announced that the European Commission (EC) has approved a label extension for Evrysdi (risdiplam) to include a new, room-temperature stable tablet for people living with spinal…
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FDA Approves NUBEQA for Metastatic Prostate Cancer
Bayer announced that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor, NUBEQA (darolutamide), for the treatment of adult patients with…
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Regeneron Boosts Obesity Pipeline with Dual GLP-1/GIP Agonist Deal
Regeneron Pharmaceuticals, Inc. announced a strategic in-licensing agreement with Hansoh Pharmaceuticals Group Company Limited (“Hansoh”) to acquire exclusive clinical development and…
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Sanofi to Acquire Blueprint Medicines, Boosting Rare Disease and Immunology Pipeline
Sanofi and Blueprint Medicines Corporation (Blueprint), a US-based, publicly traded biopharmaceutical company specializing in systemic mastocytosis (SM), a rare immunological disease,…
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Itepekimab Hits Primary Goal in One of Two COPD Phase 3 Trials
The AERIFY-1 phase 3 study evaluating itepekimab in former smokers with inadequately controlled chronic obstructive pulmonary disease (COPD) met the primary endpoint of a statistically…
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BioNTech, BMS Launch Global Partnership to Develop Cancer Therapy BNT327
BioNTech SE and Bristol Myers Squibb announced that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech’s investigational…
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Biogen and City Therapeutics Launch Collaboration to Develop RNAi-Based Therapies
Biogen Inc. and City Therapeutics, Inc., a privately held biopharmaceutical company leading the future of RNA interference (RNAi)-based medicine, announced a strategic collaboration to…
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FDA Grants Priority Review to Otsuka’s Sibeprenlimab for IgAN
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announce the U.S. Food and Drug Administration (FDA) has accepted for review…
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Lilly Boosts Pain Pipeline with SiteOne Therapeutics Acquisition
Eli Lilly and Company and SiteOne Therapeutics, Inc. announced a definitive agreement for Lilly to acquire SiteOne.
The transaction includes STC-004, a Phase 2 ready Nav1.8 inhibitor…
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Health Canada to Review GSK’s Depemokimab for Asthma and Nasal Polyps
GSK has submitted a New Drug Submission (NDS) to Health Canada for depemokimab for two proposed indications: The first indication is as an add-on maintenance treatment of asthma in…
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UCB Partners with Domino Data Lab to Modernize Life Sciences Computing
UCB, a global biopharmaceutical company, and Domino Data Lab, provider of a leading data science platform trusted by the world’s largest enterprises, announced a strategic collaboration…
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