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Results For "Food-and-Drug-Administration"

1373 News Found

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


U.S. FDA approves drug-free VNS system for stroke
Drug Approval | August 28, 2021

U.S. FDA approves drug-free VNS system for stroke

When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke