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Results For "Food-and-Drug-Administration"

1296 News Found

USFDA issues new clinical trial guidelines for cancer treatments
News | March 02, 2022

USFDA issues new clinical trial guidelines for cancer treatments

USFDA's industry recommendations and cancer Moonshot aim to improve lives of patients and their families


USFDA approves first generic version of Apokyn cartridges
Drug Approval | March 02, 2022

USFDA approves first generic version of Apokyn cartridges

TruPharma has commenced commercial marketing of Sage's approved generic cartridge product


Amneal enters U.S. biosimilars market with approval of Releukotm
Drug Approval | March 02, 2022

Amneal enters U.S. biosimilars market with approval of Releukotm

First of three Amneal biosimilars expected for U.S. approval and launch in 2022


Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review
Biotech | March 01, 2022

Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review

If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.


Lupin launches Sevelamer Hydrochloride tablets in the United States
Drug Approval | March 01, 2022

Lupin launches Sevelamer Hydrochloride tablets in the United States

Sevelamer Hydrochloride tablets, 800 mg is a generic equivalent of Renagel tablets, 800 mg


USFDA approves CITI Biopharma’s Vonjo
Drug Approval | March 01, 2022

USFDA approves CITI Biopharma’s Vonjo

Vonjo is the first approved therapy to specifically address the needs of adult cytopenic myelofibrosis patients


Unichem receives ANDA approval for bipolar disorder drug
Drug Approval | February 28, 2022

Unichem receives ANDA approval for bipolar disorder drug

Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches


Europe clears blood test to predict Alzheimer’s disease
Medical Device | February 28, 2022

Europe clears blood test to predict Alzheimer’s disease

It is the first approved blood test that can predict likely progression to Alzheimer's Disease up to six years in advance


USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy
Biotech | February 25, 2022

USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy

Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases


Jardiance approved to treat adults with heart failure regardless of left ventricular ejection fraction
Drug Approval | February 25, 2022

Jardiance approved to treat adults with heart failure regardless of left ventricular ejection fraction

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction