FDA Okays Lower Dose of Regeneron Monoclonal Antibody Cocktail
Regeneron's COVID-19 monoclonal antibody cocktail (casirivimab + imdevimab) is now authorized at half the dose for patients age 12 and older.
Category: FDA Approvals
FDA Approvals
Latest
FDA Approvals
Latest
FDA Clears Donisi Contact-free Monitoring System
The Donisi system applies a combination of proprietary optics, algorithms, and AI to remotely detect and analyze surface-level micro-vibrations caused by the heart and lungs.
FDA Approvals
Latest
FDA Analysis Confirms J&J COVID-19 Vaccine Prevents Severe Disease
A US FDA analysis of data submitted by Johnson & Johnson determined that the one-shot Jansen COVID-19 Vaccine was effective at preventing severe disease and is safe to administer.
FDA Approves Tagrisso for NSC Lung Cancer
The US FDA just approved AstraZeneca’s Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.
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FDA Approves Xolair for Nasal Polyps
Xolair is now FDA-approved across three diseases, including persistent allergic asthma, chronic idiopathic urticaria, and now nasal polyps.
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Rheonix COVID-19 MDx Assay Receives Expanded FDA Emergency Use Authorization to Include Saliva as a Sample Type
Rheonix Inc received an expanded FDA emergency use authorization that allows the use of saliva as an approved sample type.
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FDA Expected to Authorize Moderna COVID-19 Vaccine as Early as Friday
The Moderna COVID-19 vaccine was recommended for approval by an FDA advisory panel on Thursday and would be the second vaccine to receive emergency authorization.
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First OTC At-home Diagnostic Test for COVID-19 Authorized
The Ellume COVID-19 Home Test is the first over-the-counter fully at-home diagnostic test for COVID-19. Ellume is a rapid, lateral flow antigen test.
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FDA Reauthorizes BinaxNow COVID-19 Test for Home Use
The US FDA issued a new emergency use authorization for Abbott’s BinaxNow COVID-19 Ag Card Home Test, which is now authorized for use by patients at home with a prescription.
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FDA Authorizes Pfizer COVID-19 Vaccine, First Doses Administered in US
The US FDA issued emergency use authorization late Friday to Pfizer and BioNTech’s COVID-19 vaccine, and 2.9 million doses of the vaccine were shipped to 636 sites across the country.
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Trump to FDA Chief: Authorize Pfizer’s Vaccine or Resign
President Trump reportedly ordered FDA chief Stephen Hahn to authorize Pfizer’s COVID-19 vaccine candidate Friday or resign.
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FDA Okays First Combo FLU + COVID-19 Diagnostic for Home Testing
The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for home collection of patient samples to detect both COVID-19 and influenza A and B (flu).
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FDA Authorizes 3B’s Lumin to Decontaminate N95 Masks
The US FDA has issued an emergency use authorization to 3B Medical’s Lumin UVC System for the decontamination of N95 masks in certain healthcare settings.
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FDA Expands Xofluza Approval Approval for Post-exposure Prevention
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.
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FDA Approves ANDA for Intubation Anesthetic
The US FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, used to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
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