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Results For "subcutaneous-administration"

27 News Found

Shilpa Medicare receives USFDA approval for Bortezomib injection
Drug Approval | August 27, 2024

Shilpa Medicare receives USFDA approval for Bortezomib injection

Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)


Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH
News | August 27, 2024

Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab
Drug Approval | May 08, 2024

USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab

Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor


Pfizer presents marstacimab Phase 3 Data at ASH 2023
News | December 10, 2023

Pfizer presents marstacimab Phase 3 Data at ASH 2023

Demonstrate significant bleed reduction in hemophilia A and B


Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma
Drug Approval | August 16, 2023

Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma

ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity


Rystiggo needs marketing strategy to fully compete in myasthenia gravis space, says GlobalData
News | June 30, 2023

Rystiggo needs marketing strategy to fully compete in myasthenia gravis space, says GlobalData

Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024


Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation
Biotech | October 09, 2021

Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation

Gantenerumab is an investigational antibody in Phase III development for early Alzheimer's disease (AD) and a comprehensive data set with an expected readout in mid-2022