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FDA Authorizes First Direct-to-Consumer COVID-19 Test System
americanpharmaceuticalreview
December 11, 2020
The U.S. Food and Drug Administration (FDA) authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription.
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FDA Grants Accelerated Approval to naxitamab for Neuroblastoma in Bone or Bone Marrow
americanpharmaceuticalreview
December 11, 2020
The U.S. Food and Drug Administration (FDA) granted accelerated approval to naxitamab (DANYELZA, Y-mAbs Therapeutics) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients one year of age and older and ...
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Amgen’s sotorasib gets FDA breakthrough therapy status to treat advanced KRAS G12C-mutant NSCLC
pharmaceutical-business-review
December 10, 2020
Amgen has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its sotorasib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation.
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Pfizer’s pneumococcal disease vaccine scores FDA priority review
pharmatimes
December 10, 2020
The US Food and Drug Administration (FDA) has granted Pfizer’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate a priority review for the prevention of pneumococcal disease.
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US FDA staff back Pfizer COVID-19 vaccine data, authorisation likely soon
expresspharma
December 10, 2020
Data from the trial showed that the vaccine began conferring some protection to recipients even before they received the second shot, the FDA said.
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Aurobindo gets USFDA nod for dexmedetomidine HCL in 0.9% sodium chloride injection
expresspharma
December 10, 2020
Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 µg/50 mL and 400 µg/100 mL Single Dose flexible containers (bags).
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USFDA grants Zydus fast track designation for Saroglitazar to treat primary biliary cholangitis
expresspharma
December 10, 2020
Zydus announced that the United States Food and Drug Administration (USFDA) has granted ‘Fast Track Designation’ to Saroglitazar Mg for the treatment of patients with primary biliary cholangitis (PBC).
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Potential Treatment from ARCA for COVID-19 Receives Fast Track Designation
americanpharmaceuticalreview
December 09, 2020
ARCA biopharma announced the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of AB201 as a potential treatment for COVID-19.
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FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
americanpharmaceuticalreview
December 09, 2020
The U.S. Food and Drug Administration (FDA) expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu.
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Neurelis Completes Pre-IND Meeting with FDA for Acute Agitation Treatment
americanpharmaceuticalreview
December 09, 2020
Neurelis has concluded a pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding NRL-4. The FDA provided direction for the clinical development pathway for the investigational treatment.