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
The company has received approval from DCGI to begin patient enrolment and dosing in the country
Goyal reaffirmed the government’s commitment to facilitating market access, reducing trade barriers, and ensuring that Indian exporters remain globally competitive
These licenses are given in areas of infectious disease diagnostics, immunodiagnostics, and vaccine development
Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product
Edwards’ latest-generation balloon-expandable transcatheter heart valve incorporates a proprietary calcification-resistant tissue technology
The U.S. FDA issued a Form 483 with five observations
The partnership will create a first-of-its-kind, fully integrated offering for the development of mRNA drug products
Now integrates with Abbott’s instinct sensor and approved for type 2 diabetes
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