Drug Approval | January 13, 2025
USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Biocon Biologics remains committed to global standards of quality and compliance
Biocon Biologics remains committed to global standards of quality and compliance
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A
MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria
Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million
GEMTESA is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
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