Drug Approval | September 08, 2025
USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD
PendraCare Group develops, manufactures and sells innovative cardiology catheter solutions and provides design, development and manufacturing services to other global OEM’s
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
Goyal reaffirmed the government’s commitment to facilitating market access, reducing trade barriers, and ensuring that Indian exporters remain globally competitive
It will focus on interface between API and formulation manufacturing, reducing carbon footprint in formulation production, creating intellectual property, training next-generation scientists, and setting new industry benchmarks
Edwards’ latest-generation balloon-expandable transcatheter heart valve incorporates a proprietary calcification-resistant tissue technology
RTX001 represents a groundbreaking advance in the treatment of end-stage liver disease, offering new hope for patients with limited options
The partnership will create a first-of-its-kind, fully integrated offering for the development of mRNA drug products
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