Keytruda Approved in China for Esophageal Squamous Cell Carcinoma
Keytruda is now approved in China for three different types of cancer. Source: Devices & Diagnostics Letter
Akili Grabs CE Mark for Children’s Digital ADHD Treatment
The FDA last week cleared EndeavorRx for marketing in the U.S. Source: Devices & Diagnostics Letter
Glenmark Pharmaceuticals Gets Indian Approval for Favipiravir as a COVID-19 Treatment
Glenmark is also conducting phase 3 trials of favipiravir as a COVID-19 monotherapy. Source: Devices & Diagnostics Letter
Mainstay Medical’s Chronic Low Back Pain Device Approved
The company plans to launch the product in the first half of 2021. Source: Devices & Diagnostics Letter
Preceptis’ Ear Tube System Receives FDA Clearance
The system enables ear tube placements in five minutes. Source: Devices & Diagnostics Letter
FDA Warns Canadian Sterile Drugmaker for Aseptic Practices
Canadian sterile drug manufacturer Viatrexx was hit with an FDA warning letter for serious violations of aseptic practices observed during an agency inspection. Source: Devices & Diagnostics Letter
European Pharma Groups Calls for Cooperation Between EU and UK Regulators
With just six months to go before the end of the transition period in the UK’s exit from the European Union, European drug industry groups said they are “extremely concerned”…
FDA Outlines GMPs for Drugmakers Dealing With COVID-19 Infections in Workers
The FDA on Friday released guidance for drugmakers on good manufacturing practices (GMPs) for responding to COVID-19 infection in employees. Source: Drug Industry Daily
FDA Issues Template for At-Home COVID-19 Tests
The FDA has released a new Emergency Use Authorization (EUA) template to help devicemakers develop COVID-19 tests for at-home self-collection. Source: The GMP Letter
European Commission Issues Guidance on Safety Reporting
The European Commission’s Medical Device Coordination Group (MDCG) outlined in a new guidance how devicemakers should report safety incidents for clinical studies under the new Medical Device Regulation. Source: The…
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