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Metastatic Cervical Cancer Treatment Granted FDA Fast Track Designation americanpharmaceuticalreview
August 19, 2020
Akeso announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for AK104, a novel anti-PD-1/CTLA-4 bi-specific antibody, as monotherapy for the treatment of patients with recurrent or metastatic squamous cervical cancer ...
Roche receives FDA approval for Enspryng to treat NMOSD pharmaceutical-technology
August 18, 2020
Roche has received approval from the US Food and Drug Administration (FDA) for Enspryng (satralizumab-mwge) to treat adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).
FDA Accepts Evinacumab BLA for HoFH americanpharmaceuticalreview
August 17, 2020
Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a Biologics License Application (BLA) for evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous familial ...
MagVenture Receives FDA Clearance for OCD Treatment americanpharmaceuticalreview
August 17, 2020
The U.S. Food and Drug Administration (FDA) has cleared MagVenture TMS Therapy® for adjunct treatment of Obsessive-Compulsive Disorder (OCD).
US FDA approves Enspryng from Genentech for neuromyelitis optica spectrum disorder expresspharma
August 17, 2020
In two randomised controlled Phase III clinical trials, SAkuraStar and SAkuraSky studies, Enspryng demonstrated robust and sustained efficacy and a favourable safety profile in adults with AQP4 antibody-positive NMOSD.
FDA accepts application for self-administered Xolair use pharmatimes
August 14, 2020
The US Food and Drug Administration (FDA) has accepted Roche’s application for a new self-administration option for Xolair (omalizumab) across all approved US indications.
Seelos Receives FDA May Proceed Notice to Initiate a Trial of SLS-005 in ALS americanpharmaceuticalreview
August 14, 2020
Seelos Therapeutics received notice from the Food and Drug Administration (FDA) that the company may proceed with initiating a Phase IIb/III trial studying SLS-005 (trehalose) for the treatment of Amyotrophic lateral sclerosis ...
Helix Receives EUA for the Helix COVID-19 NGS Test americanpharmaceuticalreview
August 14, 2020
Helix has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Helix COVID-19 NGS Test.
Clearside Biomedical Announces FDA Acceptance of CLS-AX IND americanpharmaceuticalreview
August 14, 2020
Clearside Biomedical announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for CLS-AX (axitinib injectable suspension) ...
FDA Approves New Opioid for Intravenous Use in Hospitals, Other Clinical Settings americanpharmaceuticalreview
August 14, 2020
The U.S. Food and Drug Administration (FDA) approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom ...

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