The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease
Indoco is comprehensively working on the remedial action plan
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
The company can now expand its business horizon into the area of pharmaceutical applications in the USA
The inspection concluded with the issuance of a form 483 with five observations
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression
Subscribe To Our Newsletter & Stay Updated
