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Approvals

Drug Development
Biopharma Update on the Novel Coronavirus: April 6
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 6, 2020.
April 6, 2020
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6 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 3, 2020.
April 3, 2020
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6 min read
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BioSpace Editorial Staff
FDA
FDA Approves 1st COVID-19 Antibody Test
The U.S. Food and Drug Administration approved the first blood test that looks for the antibodies against the novel coronavirus that causes COVID-19.
April 3, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 1, 2020.
April 1, 2020
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8 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: March 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 31, 2020.
March 31, 2020
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7 min read
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BioSpace Editorial Staff
FDA
Amidst Controversy, FDA Issues EUA Allowing Anti-Malaria Drugs to Be Used to Treat COVID-19
Scientists and physicians have been cautious about use of the drug for the disease, while President Trump touted it as a “game changer.”
March 30, 2020
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4 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: March 30
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 30, 2020.
March 30, 2020
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5 min read
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BioSpace Editorial Staff
FDA
Abbott’s Point-of-Care COVID-19 Test Detects Coronavirus in as Little as 5 Minutes
Abbott’s new point-of-care test for the novel coronavirus that causes COVID-19 was approved by the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA).
March 28, 2020
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4 min read
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Mark Terry
Drug Development
Biopharma Industry News for March 27: Update on the Novel Coronavirus
A summary of daily biopharma industry news. Please check out stories that are trending on March 27, 2020.
March 27, 2020
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3 min read
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BioSpace Editorial Staff
nitpicker / Shutterstock
FDA
BMS’ Ozanimod Wins FDA Approval for Relapsing Multiple Sclerosis
Although Zeposia has now been approved in the United States, BMS said it was delaying commercialization due to the “unprecedented COVID-19 pandemic.”
March 26, 2020
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2 min read
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Alex Keown
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PRESS RELEASES
FDA
Accutar Biotechnology Announces FDA Clearance of IND Application for Phase 1 Trial of AC0176 in Prostate Cancer
December 24, 2021
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2 min read
FDA
Lecanemab granted Fast Track designation by the FDA
December 23, 2021
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6 min read
Business
INVESTIGATIONAL ALZHEIMER’S DISEASE THERAPY LECANEMAB GRANTED FDA FAST TRACK DESIGNATION
December 23, 2021
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11 min read
FDA
Radius Announces Update on TYMLOS® (abaloparatide) Label
December 23, 2021
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6 min read
FDA
Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis
December 22, 2021
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16 min read
FDA
Alnylam Comments on FDA Approval of Leqvio®, the First siRNA (RNAi Therapeutic) Approved to Reduce LDL-C
December 22, 2021
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9 min read
FDA
FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year
December 22, 2021
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10 min read
Business
FDA Approves TEZSPIRE™ (tezepelumab-ekko), AstraZeneca and Amgen’s First-in-Class Treatment for Severe Asthma
December 22, 2021
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1 min read
FDA
Philips receives FDA De Novo Clearance for IVC Filter Removal Laser Sheath - CavaClear - with Breakthrough Device Designation
December 22, 2021
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4 min read
FDA
Sight Sciences Receives FDA 510(k) Clearance of the TearCare® System for Treatment of Meibomian Gland Dysfunction (MGD), the Leading Cause of Dry Eye Disease
December 22, 2021
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9 min read
FDA
HPTN Studies Inform FDA’s Approval of ViiV Healthcare’s Long-Acting Cabotegravir Injections for HIV Prevention
December 21, 2021
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3 min read
FDA
ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Rifabutin Capsules USP
December 21, 2021
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3 min read
FDA
FDA Approves Two New Indications for XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
December 20, 2021
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22 min read
FDA
ViiV Healthcare announces US FDA approval of Apretude (cabotegravir extended-release injectable suspension), the first and only long-acting injectable option for HIV prevention
December 20, 2021
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14 min read
FDA
FDA APPROVES OTEZLA® (APREMILAST) FOR THE TREATMENT OF ADULT PATIENTS WITH PLAQUE PSORIASIS, REGARDLESS OF SEVERITY LEVEL
December 20, 2021
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18 min read
FDA
FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention
December 20, 2021
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4 min read
FDA
EDWARDS RECEIVES FDA APPROVAL FOR SAPIEN 3 WITH ALTERRA PRESTENT FOR TRANSCATHETER PULMONIC VALVE REPLACEMENT
December 20, 2021
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4 min read
FDA
OrganOx receives FDA approval for its liver normothermic machine perfusion system
December 20, 2021
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3 min read
FDA
Coherus Announces U.S. FDA Approval of YUSIMRY™ (adalimumab-aqvh)
December 20, 2021
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9 min read
FDA
Intra-Cellular Therapies Announces U.S. FDA Approval of CAPLYTA® (lumateperone) for the Treatment of Bipolar Depression in Adults
December 20, 2021
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10 min read
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