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Results For "Food-and-Drug-Administration"

1014 News Found

Caplin Steriles gets US FDA approval for blood pressure injection
News | September 08, 2021

Caplin Steriles gets US FDA approval for blood pressure injection

Labetalol hydrochloride injection USP is indicated for the control of blood pressure in severe hypertension.


Zydus Cadila’s Sitagliptin base tablets receive tentative approval from US FDA
Drug Approval | September 06, 2021

Zydus Cadila’s Sitagliptin base tablets receive tentative approval from US FDA

Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate)


Omeza Collegen Matrix gets U.S. FDA approval
Biotech | September 03, 2021

Omeza Collegen Matrix gets U.S. FDA approval

This is Omeza’s first Rx product and the first drug/device combination matrix of its kind for chronic wound care


Janssen announces U.S. FDA approval of Invega Hafyera
Drug Approval | September 02, 2021

Janssen announces U.S. FDA approval of Invega Hafyera

Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months


Ami Organics bets on strategic acquisitions as its IPO opens on Sept 1
News | September 01, 2021

Ami Organics bets on strategic acquisitions as its IPO opens on Sept 1

The company aims to continue its expansion via organic and inorganic routes to increase production capacity and product portfolio


Positive results from Pfizer’s Phase 3 trail comparing efficacy of abrocitinib and dupilumab
Drug Approval | September 01, 2021

Positive results from Pfizer’s Phase 3 trail comparing efficacy of abrocitinib and dupilumab

JADE DARE trial met co-primary and key secondary endpoints and demonstrated a safety profile consistent with previous studies for moderate to severe atopic dermatitis


US FDA clears InnoCare’s clinical trial of pan-TRK Inhibitor ICP-723
Drug Approval | August 31, 2021

US FDA clears InnoCare’s clinical trial of pan-TRK Inhibitor ICP-723

The clinical trial will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumours, and evaluate the anti-tumour efficacy of ICP-723 on NTRK fusion-positive cancers


US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184
Biotech | August 31, 2021

US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184

The drug is also intended for the treatment of glioblastoma multiforme


Dr. Reddy's announce launch two drugs in the US market
News | August 31, 2021

Dr. Reddy's announce launch two drugs in the US market

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP are available in one strength of 5 mg/2.5 mg capsules in bottle count sizes of 100


Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test
Drug Approval | August 30, 2021

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test

The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit