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FDA Grants Rafael Pharmaceuticals Orphan Drug Designation for CPI-613
americanpharmaceuticalreview
November 11, 2020
Rafael Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for CPI-613® (devimistat) for the treatment of soft tissue sarcoma.
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FDA grants EUA for Lilly’s monoclonal antibody for Covid-19 treatment
pharmaceutical-technology
November 11, 2020
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Eli Lilly and Company’s monoclonal antibody, bamlanivimab (LY-CoV555) 700mg, to treat patients recently diagnosed with Covid-19.
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Lupin’s Somerset facility gets 13 observations post US FDA inspection
expresspharma
November 10, 2020
The company does not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility.
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Alembic Pharma gets USFDA tentative nod for Palbociclib Capsules
expresspharma
November 10, 2020
Alembic Pharma announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Palbociclib Capsules, 75 mg, 100 mg, and 125 mg.
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XNK Therapeutics receives US orphan drug status for NK cell-based immunotherapy in multiple myeloma
pharmaceutical-business-review
November 09, 2020
XNK Therapeutics announced it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its leading investigational drug candidate in the treatment of multiple myeloma (MM).
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FDA Accepts for Priority Review Libtayo for Advanced Non-small Cell Lung Cancer
americanpharmaceuticalreview
November 09, 2020
Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with ...
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OncoSec Announces FDA Clearance for Trial of COVID-19 Vaccine Candidate
americanpharmaceuticalreview
November 09, 2020
OncoSec Medical announced the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for a first-in-human Phase 1 trial for CORVax12, a novel DNA-encodable vaccine against SARS-CoV-2 that the Company ...
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SomaLogic Announces New Collaboration with FDA to Advance Biosimilar Development
americanpharmaceuticalreview
November 09, 2020
SomaLogic announced an agreement with the U.S. Food and Drug Administration’s (FDA) Division of Applied Regulatory Science to evaluate the utility of large-scale analysis of proteins (proteomics) for the identification of biomarkers that may be useful ...
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reVision Therapeutics Announces FDA Grant, Orphan-Drug Designation for Stargardt Disease Treatment
americanpharmaceuticalreview
November 06, 2020
reVision Therapeutics announced the US Food and Drug Administration (FDA) has granted the Company's request to designate REV-0100 as an Orphan-Drug and a Rare Pediatric Disease Drug for the treatment of Stargardt disease.
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Qualigen Receives Positive Pre-IND Response from FDA for COVID-19 Treatment
americanpharmaceuticalreview
November 06, 2020
Qualigen Therapeutics announced receipt of written feedback to its Type B Pre-IND (Pre-Investigational New Drug application) meeting request from the U.S. Food and Drug Administration (FDA) that is in general agreement with the Company's planned ...