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Results For "Food-and-Drug-Administration"

1255 News Found

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


US FDA approves Idorsia’s insomnia drug
Drug Approval | January 21, 2022

US FDA approves Idorsia’s insomnia drug

Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain


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


Green Valley receives US FDA approval for Phase II clinical trial for Parkinson’s disease
Biotech | January 17, 2022

Green Valley receives US FDA approval for Phase II clinical trial for Parkinson’s disease

The global multi-center phase-II clinical trial will be a 36-week, multi-center, randomized, double-blind, placebo-controlled trial, followed by a 36-week open-label extension period


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


Moderna Covid-19 boosters after five-month interval: U.S. FDA
News | January 08, 2022

Moderna Covid-19 boosters after five-month interval: U.S. FDA

Earlier last week the U.S. FDA had also shortened the time to receive a Pfizer booster shot from six months to five months for everyone 12 and older


Lupin launches Molnulup to treat Covid-19
News | January 07, 2022

Lupin launches Molnulup to treat Covid-19

The drug is priced at Rs 2000 for a course of 40 tablets