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Approvals

Drug Development
Biopharma Update on the Novel Coronavirus: April 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 21, 2020.
April 21, 2020
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6 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.
April 20, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Approves Incyte’s Pemazyre for Rare Bile Duct Cancer
The U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
April 20, 2020
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3 min read
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Mark Terry
TARPEYO is the first FDA-approved drug for immunog
FDA
Seattle Genetics’ Tukysa Earns FDA Approval for HER2+ Breast Cancer
Tukysa came out of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority and Swissmedic.
April 20, 2020
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3 min read
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Mark Terry
FDA
FDA Action Alert: Sanofi, Neurocrine, Correvio and United
Here’s a look at what’s on the U.S. Food and Drug Administration’s schedule for the next two weeks.
April 17, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 17, 2020.
April 17, 2020
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6 min read
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BioSpace Editorial Staff
FDA
FDA Gives UroGen’s Jelmyto Expedited Approval for Urothelial Cancer
Jelmyto is the first and only non-surgical treatment for patients with this indication. Here’s everything you need to know about it.
April 16, 2020
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2 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 16, 2020.
April 16, 2020
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8 min read
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BioSpace Editorial Staff
FDA
FDA Approves Use of Ortho’s High-Throughput, Automated COVID-19 Antibody Test
Antibody tests, also called serological tests, test if the individual has been exposed to SARS-CoV-2, the novel coronavirus that causes COVID-19.
April 15, 2020
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2 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 15, 2020.
April 15, 2020
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7 min read
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BioSpace Editorial Staff
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PRESS RELEASES
FDA
ENDOMINA® SYSTEM, A NEW SUTURING TOOL FOR USE BY GASTROENTEROLOGISTS RECEIVES FDA CLEARANCE
January 18, 2022
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2 min read
FDA
CASI PHARMACEUTICALS ANNOUNCES CNCT19 (CD19 CAR-T) GRANTED ORPHAN DRUG DESIGNATION BY THE U.S. FDA
January 18, 2022
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4 min read
FDA
FDA Grants Breakthrough Device Designation to Diadem’s AlzoSure® Predict Prognostic Blood Test for the Early Prediction of Alzheimer’s Disease
January 18, 2022
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4 min read
FDA
Surgalign Receives FDA Clearance for HOLO Portal™ System, the World’s First AI-driven AR Guidance System for Spine Surgery
January 18, 2022
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8 min read
FDA
ADMA BioCenters Receives FDA Approval for its Fourth Plasma Collection Center Located in Goose Creek, SCFDA approval positions Company to meet or exceed target of ten or more FDA-licensed plasma collection centers by year-end 2023
January 18, 2022
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7 min read
Drug Development
SparX Group has Initiated a Phase 1 Trial of its First Organically Developed Candidate, SPX-101
January 17, 2022
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3 min read
FDA
U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis
January 14, 2022
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19 min read
FDA
U.S. FDA Approves RINVOQ® (upadacitinib) to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis
January 14, 2022
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20 min read
FDA
Glenmark Specialty S.A. (Switzerland) receives NDA Approval by the United States Food and Drug Administration (FDA) for Ryaltris™ Nasal Spray
January 14, 2022
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4 min read
FDA
Zoetis Announces FDA Approval of Solensia™ (frunevetmab injection) to Control Osteoarthritis Pain in Cats
January 13, 2022
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7 min read
FDA
FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species
January 13, 2022
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4 min read
FDA
U.S. FDA Approves New MENTOR® MemoryGel BOOST™ Breast Implant
January 13, 2022
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9 min read
FDA
FDA Grants Breakthrough Device Designation to Wavegate Corporation’s StimuLux
January 13, 2022
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1 min read
FDA
Procaps Group Acquires 1st U.S.-Based Softgel Production Facility and Pharmaceutical R&D Center to Expand Global Growth of its iCDMO Business Unit
January 12, 2022
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7 min read
FDA
Evolved by Nature Announces IDE Approval from the FDA to Initiate a Pivotal Clinical Trial for its first Activated Silk™ Dermal Filler
January 12, 2022
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3 min read
FDA
gammaCore™ Non-Invasive Vagus Nerve Stimulation(nVNS) Receives Breakthrough Device Designation for Treatment of Posttraumatic Stress Disorder (PTSD)
January 12, 2022
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8 min read
FDA
Veristat Supported Marketing Applications for 12% of all FDA Novel Drug Approvals in 2021
January 11, 2022
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4 min read
FDA
FDA approves Cochlear Nucleus Implants for unilateral hearing loss/single-sided deafness
January 11, 2022
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4 min read
FDA
Avinger Announces 510(k) Clearance for Lightbox 3 Next-Generation Imaging Console
January 11, 2022
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5 min read
Drug Development
Aramis Biosciences Announces FDA Clearance of IND Application for A197, a Novel Immunomodulatory Agent for the Treatment of Dry Eye Disease
January 11, 2022
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2 min read
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