The FDA expanded the approved indication for Genetech's Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu.
The FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.
The FDA has approved Nucala (mepolizumab) as the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), previously known as Churg-Strauss syndrome.
The US FDA has approved a new indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the treatment of asthma in patients aged 18 years and older.
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Gefapixant (MK-7264) is an investigational, orally administered, selective P2X3 receptor antagonist for the potential treatment of refractory or unexplained chronic cough.
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“A potentially unexplained illness” in a recipient of AstraZeneca’s COVID-19 vaccine candidate AZD1222 has halted the company’s phase 3 clinical trial, the AP reports.
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A phase 3 study of inhaled molgramostim therapy found the drug resulted in greater improvements in pulmonary gas transfer and functional health status than placebo in patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP).
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The FDA approved an abbreviated new drug application for cisatracurium besylate USP 20 mg/10mL (trade name Nimbex), which is indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
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The multi-site, Phase 3 clinical trial will enroll 30,000 adults in order to evaluate AstraZeneca’s investigational COVID-19 vaccine known as AZD1222.
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Remdesivir (trade name Veklury) is now authorized to treat all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.
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The FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection, which is used for patient sedation in some medical procedures.
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The FDA approved an Abbreviated New Drug Application for Lupin Ltd’s albuterol sulfate inhalation aerosol 90 mcg, a generic for Teva’s ProAir HFA.
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Convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients, the FDA said.
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The FDA accepted a sBLA for a new self-administration option for Xolair (omalizumab) across all approved US indications, according to Genetech.
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According to interim analysis reported by Vanda Pharmaceuticals Inc, tradipitant — a neurokinin-1 receptor (NK-1R) antagonist — may accelerate clinical improvement in SARS-CoV-2 (COVID-19) pneumonia.
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