The newly approved regimen offers a chemotherapy-free perioperative approach and is authorised for use across all 27 EU member states
The approval expands the use of Zytorvi beyond its initially approved indication in nasopharyngeal carcinoma (NPC)
Estradiol and Levonorgestrel Transdermal System is primarily used treat moderate to severe symptoms of menopause
The approval was supported by data from Roche’s pivotal Phase III SatraGO programme
Wanbury has commercialised a new Metformin direct-compression (DC) business in Saudi Arabia
The approved ANDA is therapeutically equivalent to the reference listed drug, Ciprodex Otic Suspension (0.3%/0.1%) by Sandoz
Zudus will submit a formal written corrective action plan within the stipulated timelines
The approval paves the way for GenSci to launch CAMCEVI 42 mg in China
Zydus holds exclusive commercialization rights for the United States and Canada and brings extensive commercial experience in the North American market for this product.
The FDA approval is backed by results from the Phase 3 PRIOH-1 trial
European GMP certification validates compliance standards at the Jadcherla finished dosage facility
The company stated it will address the observations comprehensively within the stipulated timeline
Dignify expects to begin dosing healthy volunteers in November 2026
The FDA has approved Lupin's Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe
Rhapsido is an oral, highly selective Bruton’s tyrosine kinase inhibitor
The approval is based on results from the pivotal Phase 3 SOLARIS trial, which demonstrated overall symptom improvement
The supplemental New Drug Application (sNDA) was based on the positive Phase III FIND-CKD study results
Granules India believes it may qualify for first-to-file status for Ruxolitinib Extended-Release Tablets, subject to FDA review and determination
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