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Results For "FDA"

1718 News Found

USFDA clears IND application for an intranasal RSV vaccine
Biotech | March 29, 2022

USFDA clears IND application for an intranasal RSV vaccine

The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers


USFDA approves EUA for second booster dose of Moderna
News | March 29, 2022

USFDA approves EUA for second booster dose of Moderna

50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age


Aquavit Files IND with USFDA for DTX-021, a new botulinum toxin
Drug Approval | March 25, 2022

Aquavit Files IND with USFDA for DTX-021, a new botulinum toxin

Aquavit will officially unveil the Dermatox and Microtox programs at the Annual American Academy of Dermatology, the world's largest dermatology conference scheduled from March 25-29, 2022, in Boston, MA


USFDA approves Janssen’s injectable regimen for HIV
Drug Approval | March 25, 2022

USFDA approves Janssen’s injectable regimen for HIV

Cabenuva was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's decades-long commitment to combatting HIV


USFDA approves Novartis Pluvicto to treat prostrate cancer
Drug Approval | March 24, 2022

USFDA approves Novartis Pluvicto to treat prostrate cancer

USFDA also approved complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA-positive lesions


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