Tuesday, April 7, 2020

Tuesday, April 7, 2020

Latest News

U.S. FDA: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

Today, the U.S. Food and Drug Administration (FDA) announced critical actions to advance development of novel coronavirus medical countermeasures.

ARUVANT: Receives Orphan Drug Designation for ARU-1801 for the Treatment of Sickle Cell Disease

ARU-1801 is being developed as a potential one-time treatment for patients suffering from sickle cell disease and β-thalassemia

OBI PHARMA: Granted U.S. FDA Orphan Drug Designation for the Treatment of Gastric Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

Second Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate in combination with a validated payload (MMAE) and the antibody targeting Globo H, a glycolipid antigen found on multiple tumor types.

U.S. FDA: Trump Administration takes historic steps to lower U.S. prescription drug prices

Proposed rule could allow certain prescription drugs to be imported from Canada; draft guidance explains how manufacturers could import drugs, biological products originally intended for sale in another country

U.S. FDA: Statement on low-cost biosimilar and interchangeable protein products

Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients.

U.S. FDA: Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient

Access to affordable insulin can be a matter of life and death for Americans with diabetes. If not appropriately treated, diabetes can lead to serious and life-threatening complications, including heart disease, organ failure and blindness.

U.S. FDA: Statement on new testing results, including low levels of impurities in ranitidine drugs

Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives.

FDA Health News