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Results For "U.S.-Food-and-Drug-Administration"

461 News Found

Medtronic receives USFDA approval for InterStim X system to manage bladder and bowel control
Medical Device | February 23, 2022

Medtronic receives USFDA approval for InterStim X system to manage bladder and bowel control

New InterStim X system provides 10 to 15 years of battery life without the need to recharge


Abbott's CardioMEMS HF System receives USFDA approval
Medical Device | February 22, 2022

Abbott's CardioMEMS HF System receives USFDA approval

New expanded indication provides patients suffering from earlier stages of heart failure access to the CardioMEMS HF System, a small implantable sensor that can flag early warning signs of worsening heart failure


USFDA lifts clinical hold on submission of Covaxin
News | February 20, 2022

USFDA lifts clinical hold on submission of Covaxin

Covaxin is a whole-virion inactivated Covid-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades


Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy
Drug Approval | February 20, 2022

Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy

Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear


Amneal expands injectables portfolio with four new products
Drug Approval | February 19, 2022

Amneal expands injectables portfolio with four new products

Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market


US FDA to review Amylyx new drug application for AMX0035
Drug Approval | February 19, 2022

US FDA to review Amylyx new drug application for AMX0035

AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).


USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
Drug Approval | February 18, 2022

USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib

The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022


USFDA approves Lupin’s Supplemental New Drug Application for Solosec
Drug Approval | February 17, 2022

USFDA approves Lupin’s Supplemental New Drug Application for Solosec

The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV


USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi
Biotech | February 17, 2022

USFDA accepts for Priority Review Bristol Myers Squibb’s Supplemental BLA for Breyanzi

Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years


Lilly's bebtelovimab receives EUA to treat mild-to-moderate Covid-19
Drug Approval | February 14, 2022

Lilly's bebtelovimab receives EUA to treat mild-to-moderate Covid-19

Bebtelovimab neutralizes Omicron as demonstrated by pseudo virus and authentic virus data