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FDA Approves Pneumococcal 21-Valent Conjugate Vaccine Capvaxive

Drug Topics

The vaccine covers 8 serotypes not currently covered by any FDA-approved pneumococcal vaccines.

Vaccines 199
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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

Vaccines 145
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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

The FDA Law Blog

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

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FDA Approves Blinatumomab for Adult and Pediatric Patients With B-ALL

Pharmacy Times

The FDA approved blinatumomab for treatment of patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia.

FDA 123
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. What will the future hold for clinical research?

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BD to Increase Plastic Syringe Production After FDA Warns on Imports From China

Drug Topics

Following quality concerns voiced by the FDA regarding plastic syringes made in China, medical technology company BD has announced it will increase its production of plastic syringes in the US.

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FDA clears Ipsen’s primary biliary cholangitis drug

pharmaphorum

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

FDA 108