Merck’s 21-valent pneumococcal conjugate vaccine for older adults could see US FDA approval in H1 2024, opening up another level of complexity for the CDC’s vaccine recommendations.
The Centers for Disease Control and Prevention’s Advisory Committee for Immunization Practices is gearing up to re-enter the labyrinth of pneumococcal vaccine recommendations with Merck & Co., Inc.’s 21-valent candidate V116.
Submission of a biologics license application for V116 for use in adults is expected this year, the CDC lead in...
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Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.
The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.
PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.
Antibiotics that tackle antimicrobial resistance are to be automatically included in Italy’s Innovative Medicines Fund, which is designed to provide quick access to innovative medicines.
The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
