Drug Approval | July 15, 2025
Zydus receives final approval from USFDA for Celecoxib Capsules
Celecoxib is a nonsteroidal anti-inflammatory drug
Celecoxib is a nonsteroidal anti-inflammatory drug
Capstan's lead asset, CPTX2309, is a targeted lipid nanoparticle (tLNP) that delivers an mRNA encoding an anti-CD19 chimeric antigen receptor (CAR) to CD8-expressing cytotoxic T cells in vivo
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne
IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma
Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base
Blenrep combinations could redefine treatment as early as first relapse where more effective options are needed
Approval is based on positive data from the Phase 3 ECHELON-3 trial
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older
DOVBLERON marks the 13th addition to Innovent’s commercial portfolio
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