Drug Approval | July 29, 2024
Briefs: Indoco Remedies and Alembic Pharmaceuticals
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis
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)
EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24
Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape
Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
Experienced commercial leader takes helm to expand cardiovascular diagnostic company globally and commercialize company’s flagship plaque analysis software
Lupin can receive a potential total consideration of up to USD 84 million based on future contingent milestones
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