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FDA set to review GSK’s Nucala for nasal polyps pharmatimes
December 11, 2020
The US Food and Drug Administration (FDA) is set to review GlaxoSmithKline’s (GSK) Nucala, after accepting a regulatory submission seeking approval for its use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
FDA Approves First Drug to Treat Rare Metabolic Disorder americanpharmaceuticalreview
December 11, 2020
The U.S. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder.
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.
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 ...
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.
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.
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.
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).
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).
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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