Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
his is the second license extension of a Nurix autoimmune disease program by Sanofi in the last 90 days
Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)
Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC) evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer
First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC
Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
Facility also named 2025 ISPE Facility of the Year Winner for Social Impact - Unmet Medical Needs
Record international participation reflects renewed momentum in pharma manufacturing and global sourcing, as easing tariffs fuel growth
Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne
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