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US FDA postpones foreign inspections over coronavirus outbreak expresspharma
March 12, 2020
According to Stephen M Hahn, Commissioner of Food and Drugs – Food and Drug Administration, the foreign inspections will resume as soon as feasible.
J&J NSCLC Drug Gets Breakthrough Designation contractpharma
March 12, 2020
Bispecific antibody targets activating and resistant EGFR and MET mutations and amplifications in non-small cell lung cancer.
Voltaren approved for arthritis pain over-the-counter in the US europeanpharmaceuticalreview
March 11, 2020
Voltaren Arthritis Pain has been approved by the FDA as an over-the-counter product for the temporary relief of arthritis pain.
Cadent Therapeutics Announces FDA Clearance of IND Application for Schizophrenia Treatment americanpharmaceuticalreview
March 11, 2020
Cadent Therapeutics announced the U.S. Food and Drug Administration (FDA) has provided clearance to proceed for its Investigational New Drug (IND) application for its lead cognitive disorder asset, CAD-9303, a novel, first-in-class ...
FDA and FTC issue warning letters to companies selling fraudulent COVID-19 products europeanpharmaceuticalreview
March 11, 2020
The US agencies have issued letters to seven companies, and removed online listings from others, whose products falsely claim to prevent or treat coronavirus.
Ofev® (nintedanib) approved by FDA to treat interstitial lung diseases europeanpharmaceuticalreview
March 11, 2020
The FDA has granted marketing authorisation for Ofev, as the first treatment for patients with chronic fibrosing interstitial lung diseases (ILDs).
FDA Inks Research Collaboration with AnaBios contractpharma
March 11, 2020
AnaBios announced a Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) to study adult human primary cardiomyocytes as a reference for cellular properties and drug-induced effects on cardiac function.
COVID-19 Update: FDA Foreign Inspections contractpharma
March 11, 2020
To postpone most foreign inspections through April, effective immediately.
Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections FDA
March 11, 2020
The FDA updated on the status of U.S. Food and Drug Administration inspections outside of the U.S. in response to the COVID-19 outbreak.
Immutep Receives Second IND approval for Efti from FDA americanpharmaceuticalreview
March 10, 2020
Immutep has announced the approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) for eftilagimod alpha (efti or IMP321).

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