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Telix to Acquire ITM in $1.65 Billion Radiopharmaceutical Deal
Telix Pharmaceuticals has agreed to acquire ITM Isotope Technologies Munich in a deal valued at $1.65 billion, bringing together two companies with expertise in radiopharmaceutical…
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FDA Approves Bayer’s HYRNUO for First-Line HER2-Mutated Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Bayer’s HYRNUO (sevabertinib) as a first-line treatment for adults with locally advanced or metastatic…
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FDA Approves ZANVASTRO for Rare Alexander Disease
The U.S. Food and Drug Administration (FDA) has approved Ionis Pharmaceuticals’ ZANVASTRO™ (zilganersen) for the treatment of Alexander disease (AxD) in pediatric and adult patients.…
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GSK Plans Phase III Trial for mRNA Flu Vaccine
GSK has reported positive Phase II results for its mRNA seasonal influenza vaccine candidate, with the company planning to begin a Phase III efficacy trial in September 2026.
The…
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Novartis Reports Positive Phase III Results for Remibrutinib in MS
Novartis has reported positive topline results from its Phase III REMODEL-1 and REMODEL-2 trials evaluating remibrutinib in adults with relapsing multiple sclerosis (RMS).
The oral…
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Teva Discusses Lower Medicaid Drug Prices With Trump Administration
Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd., has announced a shared commitment with the Trump Administration to explore ways to lower the cost of…
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FDA Approves Mounjaro to Reduce Cardiovascular Risk in Type 2 Diabetes
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Mounjaro (tirzepatide) to reduce the risk of major cardiovascular events in adults with type 2 diabetes who are at…
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FDA Approves Tivicay PD for Infants With HIV
The U.S. Food and Drug Administration (FDA) has approved ViiV Healthcare’s Tivicay PD (dolutegravir) for the treatment of HIV-1 infection in children weighing at least 2 kg.
The…
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FDA Approves Ziihera Combinations for HER2-Positive GEA
The U.S. Food and Drug Administration (FDA) has approved two Ziihera (zanidatamab-hrii)-based treatment regimens for the first-line treatment of adults with unresectable locally…
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Lundbeck Wins EU Orphan Designation for Cushing’s Syndrome Drug
Lundbeck has received orphan designation from the European Commission for asedebart (Lu AG13909), an experimental monoclonal antibody being developed to treat Cushing’s syndrome of…
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Takeda Wins Japan Approval for New Narcolepsy Type 1 Drug
Takeda has received approval in Japan for ORZEYFUL (oveporexton), a new oral treatment for adults with narcolepsy type 1 (NT1), a rare neurological disorder that causes excessive…
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GSK Wins Japan Approval for Hepatitis B Functional Cure
GSK has received approval in Japan for Hibsago (bepirovirsen), an antisense oligonucleotide (ASO) treatment designed to provide a functional cure for chronic hepatitis B (CHB) in…
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Charles River and Medigen Partner on Next-Generation Enterovirus Vaccine
Charles River Laboratories and Medigen Vaccine Biologics have entered into a collaboration to support the development of Medigen’s next-generation multivalent enterovirus vaccine.…
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FDA Approves Regeneron’s Pasatru for Rare Bone Disorder FOP
Regeneron Pharmaceuticals has received U.S. Food and Drug Administration approval for Pasatru (garetosmab-grts), a new treatment for adults living with fibrodysplasia ossificans…
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LEO Pharma Acquires Dersimelagon Rights for Rare Skin Diseases
LEO Pharma has agreed to acquire worldwide rights to dersimelagon from Tanabe Pharma in a deal that could reach up to $435 million in upfront and near-term milestone payments.…
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EMA Validates Pfizer and Valneva Lyme Disease Vaccine Application
The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for Pfizer and Valneva’s investigational Lyme disease vaccine, allowing the regulatory…
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Lilly Files Six Lawsuits Against Black-Market Retatrutide Sellers
Eli Lilly and Company has filed six new lawsuits against U.S. entities accused of selling unauthorized retatrutide products, escalating the pharmaceutical company's efforts to combat…
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Sobi Partners With Innate Pharma on Lacutamab in T-Cell Lymphoma
Swedish pharmaceutical company Sobi and Innate Pharma have entered into a strategic partnership to advance lacutamab, an investigational treatment for cutaneous T-cell lymphoma (CTCL),…
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Pfizer Reports Positive Phase 3 Results for LITFULO in Vitiligo
Pfizer has reported positive topline results from two Phase 3 trials evaluating LITFULO (ritlecitinib) in patients with nonsegmental vitiligo (NSV), supporting the company’s plans to…
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AbCellera, Vertex Partner on T-Cell Engagers for Autoimmune Diseases
AbCellera and Vertex Pharmaceuticals have entered into a collaboration to research, develop, manufacture and commercialize multispecific T-cell engagers (TCEs) for autoimmune diseases…
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