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Results For "antibody"

415 News Found

Lupin completes  successful Phase 3 trials for Lucentis biosimilar
Biotech | August 06, 2024

Lupin completes successful Phase 3 trials for Lucentis biosimilar

The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU


European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
Drug Approval | August 03, 2024

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance


Shilpa Biologicals receives registration approval for Adalimumab from Morocco, MoH
Drug Approval | July 24, 2024

Shilpa Biologicals receives registration approval for Adalimumab from Morocco, MoH

Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)


Syngene reports drop in Q1 FY25 revenue to Rs. 790 Cr
News | July 24, 2024

Syngene reports drop in Q1 FY25 revenue to Rs. 790 Cr

Reported profit after tax declined 19% year-on-year to Rs 76 crores


Merck completes acquisition of EyeBio
News | July 16, 2024

Merck completes acquisition of EyeBio

Acquisition strengthens and diversifies Merck’s pipeline with the addition of Restoret


FDA approves Roche’s Vabysmo PFS for three leading causes of vision loss
News | July 06, 2024

FDA approves Roche’s Vabysmo PFS for three leading causes of vision loss

Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness


Biogen completes acquisition of HI-Bio
News | July 06, 2024

Biogen completes acquisition of HI-Bio

Felzartamab demonstrated positive interim results from the Phase 2 IgA nephropathy (IgAN) study


Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
Drug Approval | July 03, 2024

Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention

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