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Tag: us fda

You Searched For "US FDA"
FDA approves twice yearly injection for treatment for adults with schizophrenia

FDA approves twice yearly injection for treatment for adults with schizophrenia

Hina Zahid3 Sept 2021 10:15 AM IST
USA: The U.S. Food and Drug Administration (FDA) has approved Invega Hafyera (paliperidone palmitate), the first-and-only twice-yearly injectable for...
FDA approves novel rehabilitation system for stroke victims

FDA approves novel rehabilitation system for stroke victims

Dr Kartikeya Kohli28 Aug 2021 9:15 AM IST
The U.S. Food and Drug Administration has approved first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper...
FDA approves drug for chronic, excessive sleepiness during daytime

FDA approves drug for chronic, excessive sleepiness during daytime

Dr. Kamal Kant Kohli13 Aug 2021 8:15 AM IST
The US Food and Drug Administration has approved a new indication for Xywav for idiopathic hypersomnia (IH) in adults. Xywav (calcium, magnesium,...
Alzheimers drug Aduhelm receives FDAs accelerated approval

Alzheimer's drug Aduhelm receives FDA's accelerated approval

Hina Zahid8 Jun 2021 10:32 AM IST
USA: Aduhelm (aducanumab) has received the US FDA's accelerated approval for the treatment of Alzheimer's disease. Aduhelm was approved using...
Diagnostic device for autism receives FDAs marketing authorization

Diagnostic device for autism receives FDA's marketing authorization

Hina Zahid3 Jun 2021 11:33 AM IST
Marketing authorization provides a new tool for helping diagnose children with ASD.USA: The US Food and Drug Administration has approved marketing...
Myfembree receives FDA approval for uterine fibroids associated heavy menstrual bleeding

Myfembree receives FDA approval for uterine fibroids associated heavy menstrual bleeding

Hina Zahid29 May 2021 7:15 AM IST
USA: The Food and Drug Administration (FDA) has approved Myfembree, a once-a-day therapy for managing heavy menstrual bleeding associated with...
FDA says no to COVID-19 Antibody Tests to Assess Immunity After Vaccination

FDA says no to COVID-19 Antibody Tests to Assess Immunity After Vaccination

MD Bureau27 May 2021 9:30 AM IST
The US Food and Drug Administration (FDA) issued a safety communication reminding the public and healthcare providers that results from currently...
FDA approves Empaveli for treatment of paroxysmal nocturnal hemoglobinuria

FDA approves Empaveli for treatment of paroxysmal nocturnal hemoglobinuria

Medha Baranwal18 May 2021 3:15 PM IST
USA: The US Food and Drug Administration has approved Apellis' Empaveli (pegcetacoplan) injection for the treatment of paroxysmal nocturnal...
FDA fast tracks novel drug for reducing adhesions after abdominal surgery

FDA fast tracks novel drug for reducing adhesions after abdominal surgery

Medha Baranwal17 May 2021 10:00 AM IST
USA: The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the Palisade Bio's investigational drug LB1148 for the...
FDA approves Zynrelef for managing postoperative pain up to 72 hours

FDA approves Zynrelef for managing postoperative pain up to 72 hours

Medha Baranwal15 May 2021 7:14 AM IST
USA: The US Food and Drug Administration (FDA) has given its approval to Heron Therapeutics' Zynrelef (bupivacaine and meloxicam) for the treatment of...
Device for smart insulin management receives FDA clearance

Device for smart insulin management receives FDA clearance

Medha Baranwal13 May 2021 11:00 AM IST
USA: A system that can help in improve insulin dosing in patients with either type 1 or type 2 diabetes has received US FDA's 510(k) clearance.The...
US FDA clears marketing of device for rehabilitation of stroke patients

US FDA clears marketing of device for rehabilitation of stroke patients

Medha Baranwal26 April 2021 2:30 PM IST
USA: The US Food and Drug Administration has authorized the marketing of a new device that assists in rehabilitation for stroke patients with upper...
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