Drug Approval | July 24, 2024
USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau
The inspections concluded with no Form 483 observations or significant critical findings
The inspections concluded with no Form 483 observations or significant critical findings
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
The Central government’s decision to exempt three more cancer medicines from customs duty is a commendable step towards making cancer drugs more affordable
Finance Minister Nirmala Sitharaman is set to present the full budget for the current financial year on July 23
Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
Findings from the SEIMC-GeSIDA Foundation (FSG) PASO-DOBLE study will include treatment efficacy, safety, and weight gain
The company will address these observations within the stipulated timeline
Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux
Felzartamab demonstrated positive interim results from the Phase 2 IgA nephropathy (IgAN) study
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