Browsing Category
Featured Articles
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
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…
Read More...
Read More...
Solid Biosciences Earns FDA Fast Track for SGT-501 Gene Therapy in CPVT
Solid Biosciences Inc., a clinical-stage company focused on genetic medicines for neuromuscular and cardiac diseases, announced it has received Fast Track designation from the U.S. Food…
Read More...
Read More...
Gefurulimab Shows Significant Improvement in Daily Function for gMG Patients in Phase III PREVAIL…
A new potential treatment for generalised myasthenia gravis (gMG), a rare and debilitating autoimmune neuromuscular disease, has shown promising results in a large international…
Read More...
Read More...
Sanofi to Acquire Vicebio, Boosting Respiratory Vaccine Portfolio
Sanofi has announced an agreement to acquire London-based biotechnology company Vicebio Ltd, expanding its presence in the respiratory vaccine space. The deal brings with it a promising…
Read More...
Read More...
AstraZeneca to Invest $50 Billion in U.S. for Drug Manufacturing and R&D
AstraZeneca announces $50 billion of investment in the United States by 2030, building on America’s global leadership in medicines manufacturing and R&D. This investment is expected…
Read More...
Read More...
Astellas Partners with Korea’s KISED to Support Drug-Discovery Startups
Astellas Pharma Inc. announced the signing of a memorandum of understanding (MoU) with the Korea Institute of Startup and Entrepreneurship Development (KISED), a government-backed…
Read More...
Read More...
ENHERTU Plus Pertuzumab Granted U.S. Breakthrough Therapy Status for HER2+ Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab for the…
Read More...
Read More...
