The open-label trial involved 105 adults with schizophrenia who were on a stable dose of an oral atypical antipsychotic for at least six weeks
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
Allergan also presented new insights on the growing population of patients on GLP-1 agonists for weight loss who are seeking aesthetic treatments
The SCOUT-HCM trial hit its primary endpoint, showing a clinically meaningful and statistically significant reduction in Valsalva left ventricular outflow tract
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 partnership has already launched with five active development programs, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework
Over the past few months, Apollo Hospitals has entered into MoUs with multiple national and international air ambulance service providers
The inspection is now closed, and no regulatory action has been recommended
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