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

594 News Found

Israel signs deal to purchase Novavax’ Covid-19 vaccine
Biotech | January 29, 2022

Israel signs deal to purchase Novavax’ Covid-19 vaccine

It would be the first protein-based alternative available in Israel


Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy
Drug Approval | January 26, 2022

Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy

Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date


USFDA rejects Merck’s gefapixant; gain approval in Japan
News | January 25, 2022

USFDA rejects Merck’s gefapixant; gain approval in Japan

Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant


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