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April 19, 2018
The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.
April 11, 2018
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.
April 09, 2018
Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
April 06, 2018
The contract manufacturing organization’s facility in Boulder, CO, has passed general inspection from FDA.
April 05, 2018
The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.
The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.
April 03, 2018
The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria.
The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.
The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.