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Results For "USFDA"

1135 News Found

USFDA approves Perrigo’s Nasonex
Drug Approval | March 21, 2022

USFDA approves Perrigo’s Nasonex

Nasonex is a registered trademark of Organon and is used by Perrigo and its affiliates under license


Alembic Pharmaceuticals receives USFDA approval for Lacosamide tablets
Drug Approval | March 21, 2022

Alembic Pharmaceuticals receives USFDA approval for Lacosamide tablets

The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older


USFDA approves Opdualag to treat metastatic melanoma
Drug Approval | March 19, 2022

USFDA approves Opdualag to treat metastatic melanoma

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab


USFDA approves Marinus’ treatment for genetic disorder
Drug Approval | March 19, 2022

USFDA approves Marinus’ treatment for genetic disorder

First and only FDA-approved treatment for seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older


USFDA approves Rinvoq for ulcerative colitis
Drug Approval | March 17, 2022

USFDA approves Rinvoq for ulcerative colitis

First approved in 2019, Rinvoq is a JAK inhibitor approved for four indications across gastroenterology, dermatology and rheumatology


USFDA EUA for point-of-care Covid-19 rapid PCR test
Medical Device | March 17, 2022

USFDA EUA for point-of-care Covid-19 rapid PCR test

DASH enables non-laboratory personnel to insert a nasal swab specimen directly into our test cartridge and then load the cartridge into the DASH instrument, providing an accurate result in about 15 minutes


Philips Capsule surveillance receives USFDA clearance
Digitisation | March 16, 2022

Philips Capsule surveillance receives USFDA clearance

Clinical surveillance solution is designed to identify emergent patient deterioration and offer enhanced patient data visibility, flexible viewing options, and clinical decision support


Granules Pharmaceuticals clears USFDA audit
News | March 15, 2022

Granules Pharmaceuticals clears USFDA audit

This is the sixth successful USFDA audit for this facility


USFDA grants Orphan Drug Designation for Akantior
Biotech | March 15, 2022

USFDA grants Orphan Drug Designation for Akantior

SIFI is currently evaluating various options for the commercialization of Akantior (polihexanide) globally, including potential out-license agreements outside its core markets


USFDA approves Zydus’ Colestipol Hydrochloride tablets
Drug Approval | March 14, 2022

USFDA approves Zydus’ Colestipol Hydrochloride tablets

It is only the second generic application approved by the USFDA