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Results For "USFDA"

1203 News Found

Healthium Medtech Sri City facility in AP gets U.S. FDA registration
News | December 08, 2021

Healthium Medtech Sri City facility in AP gets U.S. FDA registration

This is the fourth facility from the company to receive this registration


Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue
Biotech | December 07, 2021

Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue

The investigational compound, GZR18, is a novel analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone responsible for many glucoregulatory effects


Unichem Labs gets ANDA approval for schizophrenia medicine
Drug Approval | December 03, 2021

Unichem Labs gets ANDA approval for schizophrenia medicine

The product will be commercialized from Unichem's Ghaziabad plant


Medical devices industry needs reforms:  Mehernosh Daruwalla, Founder & MD, Lotus Surgicals
interviews | November 24, 2021

Medical devices industry needs reforms: Mehernosh Daruwalla, Founder & MD, Lotus Surgicals

The Indian medical devices industry has been in focus since the pandemic. From US $ 11 billion in 2020 it is expected to touch US $ 50 billion by 2025. Mehernosh Daruwalla, Founder and MD, Lotus Surgicals shares a perspective with Thomas C Thottathil on the opportunities in this sector


U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution
Drug Approval | November 23, 2021

U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution

The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies


Pfizer seeks EUA from U.S. FDA for Covid-19 drug
Biotech | November 17, 2021

Pfizer seeks EUA from U.S. FDA for Covid-19 drug

If approved or authorized, Paxlovid would be the first oral antiviral of its kind, to combat SARS-CoV-2


Alembic JV receives final approval for Mupirocin cream
Drug Approval | November 17, 2021

Alembic JV receives final approval for Mupirocin cream

The cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA


U.S FDA authorises EaseVRx, immersive virtual reality for pain relief
Drug Approval | November 17, 2021

U.S FDA authorises EaseVRx, immersive virtual reality for pain relief

EaseVRx employs the principles of cognitive behavioural therapy and other behavioural therapy techniques for the reduction of pain and pain interference


Zydus Cadila receives tentative approval for IBS tablets
Drug Approval | November 15, 2021

Zydus Cadila receives tentative approval for IBS tablets

The group now has 324 approvals and has so far filed over 400 ANDAs


Zydus Cadila receives approval for glycopyrrolate injection
Drug Approval | November 10, 2021

Zydus Cadila receives approval for glycopyrrolate injection

Glycopyrrolate injection can also be used in adults as an adjunctive therapy for the treatment of gastrointestinal ulcer when a rapid effect is desired or when oral medication is not tolerated