The investigational new drug application with FDA was actually for NEOK002, an EGFR/MUC1-targeting antibody-drug conjugate aimed at solid tumors
The FDA approval makes PD-L1 IHC 22C3 pharmDx the only companion diagnostic approved to detect tumors expressing PD-L1 in esophageal or GEJ carcinoma patients for KEYTRUDA treatmen
The US FDA has approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia
Sugammadex injection is bioequivalent to Merck’s Bridion injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery
The approval covers pediatric patients without a matched sibling donor for stem cell transplant
Paroxetine extended-release tablets are indicated for the treatment of major depressive disorder
New targeted pill offers hope for adults and teens with moderate-to-severe plaque psoriasis
The newly classified assays join Roche’s Ionify 25-Hydroxy Vitamin D total assay in a growing U.S. portfolio
ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025
The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options
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