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November 12, 2021
The White House has nominated Robert Califf to head FDA, ending months of uncertainty about the future path for the high-profile agency.
The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies.
November 11, 2021
The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.
November 10, 2021
The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.
The winners of the 18th CPhI Pharma Awards, which are given as a recognition of ‘Excellence in Pharma’, were announced on November 9, 2021, in Milan.
Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.
November 09, 2021
EPRONTIA (topiramate) oral solution, 25 mg/mL has been approved to treat certain seizures in patients two years of age or older and for use to prevent migraine in patients 12 years of age and older.
The agency is reviewing data on the use of molnupiravir (MK 4482 or Lagevrio) for potential use to treat COVID-19 prior to authorization.
November 08, 2021
Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.
November 05, 2021
The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.