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Latest From BioMarin Pharmaceutical Inc.
AstraZeneca’s Nirsevimab: US FDA Wants Input On How It Would Fit With Pediatric RSV Vaccines
Proposed RSV prevention treatment for infants and neonates showed efficacy with few safety concerns, but with pediatric vaccines in development, FDA wants the Antimicrobial Drugs Advisory Committee to discuss what data would be needed to determine appropriate use in vaccinated infants and mothers.
ASCO 2023 – Bicara Eyes Head And Neck Niche
Impressive data in HPV-negative disease, potentially beating Keytruda, has the private group making pivotal plans.
Jazz Hits High Note With Updated Zanidatamab Data In Biliary Tract Cancer At ASCO
The company said it is in talks with the US FDA for an accelerated approval filing of the HER2-directed bispecific antibody, which showed better ORR and PFS than the standard of care.
US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month
Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.
Company Information
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Biotechnology
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- Huxley Pharmaceuticals, Inc.
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