USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters

Shilpa Medicare’s acceptance by USFDA of NDA filed by its CDMO partner Unicycive for Oxylanthanum Carbonate

USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI

The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit

Lupin receives tentative approval from USFDA for Raltegravir Tablets

This product will be manufactured at Lupin’s Nagpur facility in India

Briefs: Sun Pharmaceutical Industries and Biocon Biologics

The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI

Zydus receives final approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 mg

Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad

FDA approves VYALEV for adults living with advanced parkinson's disease

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 Remedies receives OAI status from USFDA for Goa plant 2 & 3

Indoco is comprehensively working on the remedial action plan

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis