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3093 News Found

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


EC approves Tepmetko to treat non-small cell lung cancer
Drug Approval | February 19, 2022

EC approves Tepmetko to treat non-small cell lung cancer

Tepmetko is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment


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


Hetero’s molnupiravir Phase III studies show 65 % reduction in hospitalisation
News | February 19, 2022

Hetero’s molnupiravir Phase III studies show 65 % reduction in hospitalisation

Early viral clearance (negative RT-PCR) and significant clinical improvement were observed within five days of administering the antiviral drug. There were no fatalities reported during the study


Indian pharma industry needs a winning partnership
News | February 19, 2022

Indian pharma industry needs a winning partnership

The focus should be on streamlining regulations, developing new molecules, increased industry academia collaboration and tapping the potential of traditional medicines


Arrowhead Pharmaceuticals initiates study of ARO-C3
News | February 19, 2022

Arrowhead Pharmaceuticals initiates study of ARO-C3

AROC3-1001 is a phase 1/2, placebo controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-C3


Interactive App from rXperius to provide pharma industry with patient insights
Digitisation | February 18, 2022

Interactive App from rXperius to provide pharma industry with patient insights

The insights collected by the app will support the pharmaceutical industry’s efforts to further improve patients’ lives by providing actionable data on patients’ individual experiences


ValGenesis selected for validating French pharma firm
Digitisation | February 18, 2022

ValGenesis selected for validating French pharma firm

With ValGenesis VLMS, change control driven validation activities are reduced from weeks to mere hours, and the company gains faster access to detailed metrics that help reduce costs and cycle time


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 clears Kairos Pharma’s IND to treat prostrate cancer
Biotech | February 18, 2022

USFDA clears Kairos Pharma’s IND to treat prostrate cancer

Phase 2 clinical trial to begin in 2022 with participation by Cedars Sinai Medical Center, University of Utah, and City of Hope