49 reports

The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in December 2017.

  • Dementia
  • Pharmaceutical
  • Therapy
  • United States
  • Product Initiative

Pfizer sells prescription medicines through wholesalers, retailers, hospitals, clinics, government agencies and pharmacies.

  • Dementia
  • United States
  • Company
  • Product Initiative
  • Eisai Co., Ltd.

The Prescription Drug User Fee Act (PDUFA) action date is November ##, 2012.

  • Cancer
  • Dementia
  • United States
  • Product Initiative
  • Exelixis, Inc.

THE FDA HAS ASSIGNED A PRESCRIPTION DRUG USER FEE ACT (PDUFA) TARGET DATE OF OCTOBER ##, 2012.

  • Cell Therapy
  • Dementia
  • United States
  • Product Initiative
  • Anavex Life Sciences Corp.

The company' s core SHIONOGI & CO LTD pharmaceuticals product business consists of three categories, namely, Prescription Drugs, OTC Drugs and Diagnostics.

  • Dementia
  • Pharmaceutical
  • Therapy
  • United States
  • Product Initiative

The company' s product portfolio includes biologics, prescription pharmaceuticals and vaccines.

  • Dementia
  • United Kingdom
  • World
  • Product Initiative
  • Actinogen Limited

Small molecules act as PSEN## (presenilin ##) inhibitor.

  • Dementia
  • United States
  • World
  • Product Initiative
  • NeuroGenetic Pharmaceuticals, Inc.

The company' s product portfolio includes biologics, prescription pharmaceuticals and vaccines.

  • Dementia
  • Therapy
  • United States
  • Product Initiative
  • Eisai Co., Ltd.

The company' s product portfolio includes biologics, prescription pharmaceuticals and vaccines.

  • Dementia
  • Therapy
  • United States
  • Product Initiative
  • Synovo GmbH

Ono Pharmaceutical Co Ltd (Ono Pharmaceutical) is a research-based pharmaceutical company, which carries out the discovery, production and sale of prescription pharmaceuticals and diagnostic reagents.

  • Dementia
  • Mental Health
  • Therapy
  • World
  • Product Initiative

Similarly, the Universities' portfolio in Phase III, Preclinical and Discovery stages comprises ##, ## and ## molecules, respectively.

  • Dementia
  • Pharmaceutical
  • Therapy
  • United States
  • Product Initiative

The company' s product portfolio includes biologics, prescription pharmaceuticals and vaccines.

  • Dementia
  • Therapy
  • United States
  • Product Initiative
  • AB Science SA

AC IMMUNE SA Eisai Co Ltd (Eisai) is a pharmaceutical company that undertakes the research, development, manufacture and marketing of pharmaceuticals, including over-the-counter (OTC) drugs, prescription medicines and generics.

  • Dementia
  • Therapy
  • United States
  • Product Initiative
  • AC Immune SA

THE DRUG CANDIDATE IS BASED ON STEMSCREEN-## PLATFORM.

  • Dementia
  • United States
  • World
  • Product Initiative
  • NeuroGenetic Pharmaceuticals, Inc.

The company' s product portfolio includes biologics, prescription pharmaceuticals and vaccines.

  • Dementia
  • United States
  • Company Operations
  • Product Initiative
  • Eisai Co., Ltd.

AstraZeneca plc (AstraZeneca) is a biopharmaceutical company that endeavors to discover, produce and commercialize a wide range of prescription drugs.

  • Dementia
  • Pharmaceutical
  • Therapy
  • United States
  • Product Initiative

Merck & Co Inc (Merck) is a biopharmaceutical company that focuses on the discovery, development, manufacture and commercialization of prescription medicines, biologic therapies, vaccines and animal health products.

  • Dementia
  • Pharmaceutical
  • Therapy
  • United States
  • Product Initiative

The company' s product portfolio includes biologics, prescription pharmaceuticals and vaccines.

  • Dementia
  • Therapy
  • United States
  • Product Initiative
  • AB Science SA

Eisai Co Ltd (Eisai) is a pharmaceutical company that undertakes the research, development, manufacture and marketing of pharmaceuticals, including over-the-counter (OTC) drugs, prescription medicines and generics.

  • Dementia
  • Therapy
  • United States
  • Product Initiative
  • QR Pharma, Inc.

THE COMPANY' S PRESCRIPTION DRUGS INCLUDE OSTEOPOROSIS, ANTIBIOTICS, ANTIDIARRHEAL, LIVER SUPPLEMENTS AND ANTIEMETICS.

  • Cancer
  • Clinical Trial
  • Dementia
  • Therapy
  • Oryzon Genomics S.A.

The company' s product portfolio includes biologics, prescription pharmaceuticals and vaccines.

  • Dementia
  • Psychotic Disorder
  • United States
  • Product Initiative
  • Anavex Life Sciences Corp.

CHRONOS THERAPEUTICS LTD Eisai Co Ltd (Eisai) is a pharmaceutical company that undertakes the research, development, manufacture and marketing of pharmaceuticals, including over-the-counter (OTC) drugs, prescription medicines and generics.

  • Dementia
  • Pharmaceutical
  • United States
  • Product Initiative
  • Eisai Co., Ltd.

Eisai Co Ltd (Eisai) is a pharmaceutical company that undertakes the research, development, manufacture and marketing of pharmaceuticals, including over-the-counter (OTC) drugs, prescription medicines and generics.

  • Dementia
  • Pharmaceutical
  • Therapy
  • United States
  • Product Initiative

ALS patients received riluzole plus masitinib ##. ## mg/ kg/ day, ##. ## mg/ kg/ day, or placebo (##:##:##) up to ## weeks.

  • Dementia
  • Neurological Disorder
  • United States
  • Product Initiative
  • AB Science SA

A PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE IS SET FOR DECEMBER ##, 2019.

  • Dementia
  • Monoclonal Antibody
  • United States
  • Company
  • Product Initiative

The company offers a wide range of products including prescription medicines, consumer health care products, animal health care products and biopharmaceuticals.

  • Antimalarials
  • Dementia
  • United States
  • Product Initiative
  • Genervon Biopharmaceuticals, LLC

In addition, a marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee.

  • Cell Therapy
  • Dementia
  • United States
  • Product Initiative
  • BrainStorm Cell Therapeutics Inc.

The company offers a wide range of products including prescription medicines, consumer health care products, animal health care products and biopharmaceuticals.

  • Antimalarials
  • Dementia
  • United States
  • Product Initiative
  • Genervon Biopharmaceuticals, LLC

THE COMPANY' S PRODUCT PORTFOLIO INCLUDES BIOLOGICS, PRESCRIPTION PHARMACEUTICALS AND VACCINES.

  • Dementia
  • Therapy
  • Australia
  • Product Initiative
  • Actinogen Limited

The company offers prescribed medicines including ethical drugs, mucodyne, kipres, desalex, flutiform, pentasa, ketas and uritos.

  • Blood Disease
  • Dementia
  • Hospital
  • Therapy
  • MediciNova, Inc.