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FDA Approves Updated Label for Endari americanpharmaceuticalreview
November 12, 2020
Emmaus Life Sciences has announced revised prescribing information for Endari® to better inform healthcare professionals and sickle cell disease patients.
Novavax COVID-19 vaccine granted Fast Track Designation by U.S. FDA worldpharmanews
November 11, 2020
Novavax, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate.
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.
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.
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.
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.
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).
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 ...
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 ...
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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