News | March 06, 2025
Zydus Lifesciences launches ANVIMO
ANVIMO will be available in dosages of 240 mg and 480 mg
ANVIMO will be available in dosages of 240 mg and 480 mg
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
For the 2024 outlook, sales growth is now expected to be 22-28% at CER
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)
Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID?19 in an immunocompromised patient population
SUPERNOVA is a large Phase III global trial providing the only efficacy data in immunocompromised patients
Colchicine Capsules are indicated for prophylaxis of gout flares in adult
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