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4483 News Found

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


US FDA to review Amylyx new drug application for AMX0035
Drug Approval | February 19, 2022

US FDA to review Amylyx new drug application for AMX0035

AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).


Abbott recalls powder formula manufactured at Sturgis, Mich., plant
News | February 19, 2022

Abbott recalls powder formula manufactured at Sturgis, Mich., plant

Recall does not include any metabolic deficiency nutrition formulas


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


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


Top five pharma looks to LifeSphere IDMP for regulatory readiness
News | February 18, 2022

Top five pharma looks to LifeSphere IDMP for regulatory readiness

ArisGlobal's industry-leading regulatory software chosen by top pharmaceutical company for IDMP preparation and global readiness