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Results For "U.S.-Food-and-Drug-Administration"

461 News Found

Medtronic gets USFDA approval of spinal cord stimulation therapy
Medical Device | January 25, 2022

Medtronic gets USFDA approval of spinal cord stimulation therapy

Studies show significant reduction in pain and improved quality of life for patients treated with spinal cord stimulation compared to medication management alone


USFDA approves IND application for Allied’s cancer treatment
Biotech | January 24, 2022

USFDA approves IND application for Allied’s cancer treatment

APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types


Pfizer and OPKO update on the Biologics License Application for Somatrogon
Biotech | January 22, 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward


USFDA expands use of Remdesivir  for Covid-19
News | January 22, 2022

USFDA expands use of Remdesivir for Covid-19

Previously, the use of the drug was limited to patients requiring hospitalization


Lannett receives USFDA safety review for biosimilar insulin glargine
Biotech | January 22, 2022

Lannett receives USFDA safety review for biosimilar insulin glargine

Go-ahead for pivotal clinical trial which is expected to commence by March


Palleon announces IND clearance for first-in-class cancer immunotherapy
Biotech | January 21, 2022

Palleon announces IND clearance for first-in-class cancer immunotherapy

Phase 1/2 trial of E-602 expected to open in Q1 2022 in patients with solid tumours


VFMCRP receives EU approval for Tavneos for the treatment of ANCA-associated vasculitis
Drug Approval | January 20, 2022

VFMCRP receives EU approval for Tavneos for the treatment of ANCA-associated vasculitis

First launches expected in H1 2022


U.S. FDA approves treatment to control pain in cats with osteoarthritis
Drug Approval | January 14, 2022

U.S. FDA approves treatment to control pain in cats with osteoarthritis

It is the first monoclonal antibody drug for use in any animal species


Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021
News | January 12, 2022

Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021

This surpasses the number of approvals supported in 2020


Novavax and Serum file EUA for Covovax in South Africa
Biotech | January 10, 2022

Novavax and Serum file EUA for Covovax in South Africa

Novavax' vaccine has received authorizations of the vaccine in over 170 countries