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Food and Drug Administration (FDA)

NEWS
Drug Development
Biopharma Update on the Novel Coronavirus: September 18
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 18, 2020.
September 17, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.
September 16, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 14, 2020.
September 14, 2020
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3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 11
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 11, 2020.
September 10, 2020
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2 min read
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BioSpace Editorial Staff
Treatment of asthma coming very soon.
FDA
GSK’s Trelegy Ellipta Wins Approval as Treatment of Asthma
GlaxoSmithKline’s Trelegy Ellipta won regulatory approval for the treatment of asthma in patients aged 18 years and older. Here’s what you need to learn.
September 10, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: September 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 9, 2020.
September 8, 2020
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4 min read
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BioSpace Editorial Staff
Pictured: A person performing a COVID-19 test/iSto
Drug Development
NanoViricides Outlines Two-Pronged Approach to Developing COVID-19 Therapies
NanoViricides, based in Shelton, Connecticut, outlined its approach to developing therapies against COVID-19 at the LD 500 investor conference yesterday.
September 4, 2020
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3 min read
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Mark Terry
Policy
FDA Action Alert: Possible COVID-19 Action and Mallinckrodt’s Terlipressin
It’s entirely possible that what we will be seeing most from the U.S. Food and Drug Administration for the month of September is related to treatments and vaccines for COVID-19.
September 3, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: September 4
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 4, 2020.
September 3, 2020
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3 min read
 · 
BioSpace Editorial Staff
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JOBS
IN THE PRESS
Policy
TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-203-A0201 Targeting PRAME
August 29, 2023
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7 min read
Policy
Faron Receives FDA Orphan Drug Designation for Bexmarilimab in Acute Myeloid Leukemia
August 29, 2023
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6 min read
FDA
U.S. FDA Approves Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require Transfusions
August 28, 2023
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15 min read
Policy
Tourmaline Bio Announces FDA Clearance of Investigational New Drug (IND) Application for TOUR006, an anti-IL-6 antibody with a differentiated profile for the treatment of thyroid eye disease (TED)
August 28, 2023
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7 min read
FDA
ANI Pharmaceuticals Announces the FDA Approval and Launch of Estradiol Gel, 0.1%
August 28, 2023
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3 min read
Policy
Harbour BioMed Announces US IND Clearance of Its First ADC Program HBM9033 in Solid Tumors
August 28, 2023
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3 min read
Policy
FDA Roundup: August 25, 2023
August 25, 2023
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2 min read
Policy
AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment
August 25, 2023
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2 min read
Biotech Beach
Now Available – XDEMVY™ (lotilaner ophthalmic solution) 0.25%, the First and Only FDA Approved Treatment for Demodex Blepharitis
August 24, 2023
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7 min read
Policy
Medtronic issues statement on the FDA Circulatory Systems Devices Advisory Panel vote for the Symplicity Spyral Renal Denervation System
August 23, 2023
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4 min read
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