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Results For "FDA"

2080 News Found

Pfizer granted USFDA Breakthrough Therapy Designation for RSV vaccine candidate
Drug Approval | March 24, 2022

Pfizer granted USFDA Breakthrough Therapy Designation for RSV vaccine candidate

The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age


Lupin receives approval from USFDA for Sildenafil for Oral Suspension
Drug Approval | March 24, 2022

Lupin receives approval from USFDA for Sildenafil for Oral Suspension

The product will be manufactured at Lupin’s facility in Goa, India


Indoco Remedies receives USFDA approval for Lacosamide tablets
Drug Approval | March 22, 2022

Indoco Remedies receives USFDA approval for Lacosamide tablets

According to IQVIA sales data for the period ending January 2022, Vimpat tablets market achieved annual sales of approx. US $ 1.7 billion


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 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 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 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