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Results For "FDA"

1712 News Found

Granules Inc., receives ANDA approval for prazosin hydrochloride
Drug Approval | December 28, 2021

Granules Inc., receives ANDA approval for prazosin hydrochloride

The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health


Sun Pharma receives DCGI approval for Molxvir in India
Drug Approval | December 28, 2021

Sun Pharma receives DCGI approval for Molxvir in India

The product is expected to be available in a week’s time


Torrent Pharma to launch molnupiravir under the brand name Molnutor in India
Drug Approval | December 28, 2021

Torrent Pharma to launch molnupiravir under the brand name Molnutor in India

DCGI approved the drug based on the review of clinical data


Aurobindo to manufacture and market molnupiravir
Drug Approval | December 28, 2021

Aurobindo to manufacture and market molnupiravir

The drug will be marketed under the brand name Molnaflu


Biocon partner Equillium initiates clinical study for Itolizumab in Lupus Nephritis
Biotech | December 24, 2021

Biocon partner Equillium initiates clinical study for Itolizumab in Lupus Nephritis

Systemic Lupus Erythematosus, or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the U.S. has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000


Evusheld neutralises Omicron in latest studies
News | December 23, 2021

Evusheld neutralises Omicron in latest studies

Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19


Cipla receives final approval for Lanreotide injection
Drug Approval | December 20, 2021

Cipla receives final approval for Lanreotide injection

It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours


WHO grants EUL for Covovax
Drug Approval | December 20, 2021

WHO grants EUL for Covovax

First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine


TeleRay and Radiobotics to provide radiology AI
News | December 20, 2021

TeleRay and Radiobotics to provide radiology AI

TeleRay partners with Radiobotics, adding Artificial Intelligence to their pre-existing integrated best-in-class medical image and patient information distribution platform


Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant
News | December 17, 2021

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research