Browsing Tag
US FDA
379 posts
Lupin Limited announces satisfactory FDA inspection results for Mandideep facility
Global pharmaceutical major, Lupin Limited (Lupin), has announced receiving the Establishment Inspection Report (EIR) from the United States…
Roche’s Vabysmo gains FDA approval for treating retinal vein occlusion
Pharma giant Roche has secured the U.S. FDA’s approval for Vabysmo (faricimab) in treating macular edema after retinal…
FDA approves Lilly’s Omvoh: A breakthrough for ulcerative colitis treatment
The U.S. Food and Drug Administration (FDA) has sanctioned Eli Lilly and Company’s Omvoh (mirikizumab-mrkz) infusion (300 mg/15…
Aurobindo Pharma subsidiary earns FDA approval for Testosterone Cypionate Injection
In a significant development for the pharmaceutical industry, Aurobindo Pharma Limited’s dedicated subsidiary, Eugia Pharma Specialities Limited, has…
Lupin gains FDA nod for generic Diflucan Tablets production
Lupin Limited, a recognized global pharmaceutical powerhouse, proudly announced its receipt of the much-anticipated approval from the US…
FDA expands VOXZOGO approval for all ages with open growth plates
BioMarin Pharmaceutical Inc., a leading global biotechnology entity, unveiled that its drug, VOXZOGO (vosoritide), has received the green…
FDA approves Zydus Lifesciences’ ZITUVIO tablets for Type 2 diabetes
Zydus Lifesciences Limited announced today that the U.S. Food and Drug Administration (FDA) has granted approval for its…
Glenmark Pharmaceuticals secures FDA approval for generic version of Otezla Tablets
Glenmark Pharmaceuticals Ltd. has successfully secured the final approval from the United States Food & Drug Administration (U.S.…
GE HealthCare launches Allia IGS Pulse after FDA 510(k) clearance
GE HealthCare (Nasdaq: GEHC) has stepped into a new era of cardiovascular imaging by announcing the FDA 510(k)…
Lupin Limited secures tentative FDA nod for generic Apalutamide Tablets
In a significant stride for global pharmaceuticals, Lupin Limited has garnered tentative approval from the United States Food…