Diagnostic Center | August 26, 2024
Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA
Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India
Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India
Finerenone significantly reduced the composite of cardiovascular death and total (first and recurrent) heart failure events compared to placebo in addition to usual therapy
The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
Pivotal OASIS 1 and 2 Phase III studies of investigational compound elinzanetant achieved a statistically significant reduction in frequency and severity of vasomotor symptoms
If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
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