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DATROWAY Approved in China for Previously Treated HR+/HER2- Metastatic Breast Cancer
China’s National Medical Products Administration (NMPA) has approved DATROWAY (datopotamab deruxtecan) for the treatment of adults with unresectable or metastatic hormone receptor (HR)…
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Genentech and Roche Break Ground on New Manufacturing Facility in North Carolina
Genentech, a member of the Roche Group, officially broke ground on its newest U.S. manufacturing site in Holly Springs, North Carolina, marking a major milestone as the biotech giant…
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AbbVie to Acquire Gilgamesh’s Bretisilocin, Boosting Psychiatry Pipeline for Depression
AbbVie and Gilgamesh Pharmaceuticals have entered into a definitive agreement under which AbbVie will acquire Gilgamesh’s lead investigational candidate, bretisilocin, a next-generation…
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Lilly’s Oral GLP-1, Orforglipron, Succeeds in Third Phase 3 Trial, Paving Way for Global Obesity…
Eli Lilly and Company announced that its investigational oral GLP-1 receptor agonist, orforglipron, delivered significant weight loss and blood sugar control in a Phase 3 clinical trial…
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Kite to Acquire Interius BioTherapeutics to Expand In Vivo Cell Therapy Capabilities
Kite, a Gilead Company, announced it will acquire Interius BioTherapeutics, a privately held biotech firm pioneering in vivo CAR therapies, in a $350 million deal aimed at advancing…
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Johnson & Johnson Invests $2B in New State-of-the-Art Manufacturing Facility in North Carolina
Johnson & Johnson has announced a major expansion of its U.S. manufacturing capabilities with a $2 billion, 10-year investment in a new 160,000+ square foot facility at FUJIFILM’s…
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Jazz Pharmaceuticals Signs Exclusive Licensing Deal with Saniona for SAN2355 Development
Jazz Pharmaceuticals plc and Saniona have entered into a global licensing agreement granting Jazz exclusive worldwide rights to develop and commercialize SAN2355, a subtype-selective…
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Boehringer Ingelheim, AnGes Ink Manufacturing Deal for HGF Gene Therapy
Boehringer Ingelheim has signed a contract development and manufacturing agreement with AnGes Inc. to produce the drug substance for AnGes' investigational Hepatocyte Growth Factor…
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European Commission Approves OGSIVEO for Adult Desmoid Tumors
SpringWorks Therapeutics, part of Merck KGaA, Darmstadt, Germany, announced that the European Commission (EC) has granted marketing authorization for OGSIVEO (nirogacestat), an oral…
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FDA Grants Breakthrough Status to Izalontamab Brengitecan for EGFR-Mutant Lung Cancer
SystImmune Inc. and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan…
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FDA Grants Accelerated Approval to Boehringer’s HERNEXEOS for HER2-Mutant Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to HERNEXEOS (zongertinib tablets), Boehringer Ingelheim’s new oral targeted therapy for adults with…
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FDA Grants Priority Review to Gepotidacin for Oral Treatment of Gonorrhea
GSK announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for gepotidacin, an oral antibiotic, for the treatment of…
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FDA Expands Approval of AJOVY as First Anti-CGRP Preventive for Pediatric Episodic Migraine
In a significant development for pediatric migraine care, Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for AJOVY…
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FDA Accepts Bristol Myers Squibb’s Priority Review for Breyanzi in Relapsed/Refractory Marginal Zone…
Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) for Breyanzi (lisocabtagene…
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AstraZeneca and Revna Biosciences Expand Lung Cancer Treatment Access in Ghana
Since announcing their partnership in April 2025, AstraZeneca and Revna Biosciences have made significant strides in improving lung cancer care across Ghana, from early diagnosis to…
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FDA Advises Sarepta to Lift Pause and Resume ELEVIDYS Shipments for Ambulatory Duchenne Patients
Sarepta Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has informed the company it may lift its voluntary pause on shipments of ELEVIDYS (delandistrogene…
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Boehringer Ingelheim and Re-Vana Partner to Develop Long-Acting Eye Disease Therapies
Boehringer Ingelheim and Re-Vana Therapeutics, a US- and UK-based developer of ocular drug delivery technologies, have announced a strategic collaboration and licensing agreement aimed…
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GSK and Hengrui Pharma Partner to Develop Up to 12 Innovative Medicines in Key Therapeutic Areas
GSK plc has announced a major strategic collaboration with Hengrui Pharma, aimed at developing up to 12 innovative medicines across Respiratory, Immunology & Inflammation…
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Gilead’s Twice-Yearly Lenacapavir Gets Positive CHMP Opinion for HIV Prevention
Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending…
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EU Regulators Back Alhemo Label Expansion for Haemophilia A and B Without Inhibitors
Novo Nordisk announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an expanded label for Alhemo…
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