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Results For "FDA-approval"

460 News Found

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


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


U.S. FDA approves Leo Pharma’s Adbry
Drug Approval | December 29, 2021

U.S. FDA approves Leo Pharma’s Adbry

Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022


U.S. FDA issues Emergency Use Authorisation for Merck’s molnupiravir
News | December 24, 2021

U.S. FDA issues Emergency Use Authorisation for Merck’s molnupiravir

The authorization provides an additional treatment option against the Covid-19 virus in the form of a pill that can be taken orally


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


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


USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria
Biotech | December 16, 2021

USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria

ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains


Zydus receives  USFDA  approval for Phase2(b)/3 trial of Saroglitazar
Biotech | December 10, 2021

Zydus receives USFDA approval for Phase2(b)/3 trial of Saroglitazar

Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)


U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery
Drug Approval | November 30, 2021

U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery

It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal


Syngene reports better than expected revenues, margin pressure in Q1FY22: ICICI Direct
News | October 25, 2021

Syngene reports better than expected revenues, margin pressure in Q1FY22: ICICI Direct

Key takeaways of recent quarter & conference call highlights