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Approvals

Policy
Biopharma Update on the Novel Coronavirus: September 2
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 2, 2020.
September 1, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: August 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 31, 2020.
August 31, 2020
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2 min read
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BioSpace Editorial Staff
FoundationOne Liquid CDx got green flag from FDA.
FDA
FoundationOne Liquid CDx Wins Approval for Comprehensive Pan-Tumor Liquid Biopsy
With a new regulatory approval in hand for its FoundationOne Liquid CDx, Foundation Medicine said it plans for the product to be available for commercial use by Friday, Aug. 28.
August 27, 2020
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2 min read
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Alex Keown
FDA
FDA Approves New Acne Treatment Winlevi with New Mechanism of Action in 40 Years
The U.S. Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi. Let’s look at how this new acne treatment was developed.
August 27, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 26, 2020.
August 25, 2020
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4 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: August 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 24, 2020.
August 24, 2020
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2 min read
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BioSpace Editorial Staff
FDA
FDA Greenlights Novartis’ Kesimpta for Multiple Sclerosis
The U.S. Food and Drug Administration (FDA) approved Novartis’ Kesimpta (ofatumumab) for relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
August 21, 2020
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2 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: August 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 21, 2020.
August 20, 2020
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5 min read
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BioSpace Editorial Staff
FDA
Mylan Wins Approval for First Generic to Biogen’s MS Drug Tecfidera
This morning, Mylan announced the launch of its new generic offering, dimethyl fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis.
August 19, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 19, 2020.
August 17, 2020
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2 min read
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BioSpace Editorial Staff
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PRESS RELEASES
FDA
Pliant Therapeutics Receives FDA Fast Track Designation for PLN-74809 for the Treatment of Idiopathic Pulmonary Fibrosis
May 3, 2022
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5 min read
FDA
SeaStar Medical Granted FDA Breakthrough Device Designation for a Novel Immunomodulatory Therapy for Acute Kidney Injury Patients
May 3, 2022
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10 min read
FDA
ZEUS Scientific Announces FDA Clearance for the ZEUS dIFine® IFA Imaging and Pattern Recognition System
May 3, 2022
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2 min read
FDA
Vitti Labs Announces FDA Approval of Phase II IND Clinical Trial of Combination Mesenchymal Stem Cell and Exosome Treatment of Pulmonary Fibrosis Secondary to Novel Corona Virus Infection (COVID-19)
May 2, 2022
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2 min read
FDA
Silk Road Medical Announces FDA Approval of Expanded Indications for the ENROUTE® Transcarotid Stent System
May 2, 2022
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4 min read
FDA
Limaca Medical Receives FDA Breakthrough Device Designation
May 2, 2022
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4 min read
FDA
Orphalan announces FDA approval of Cuvrior™ for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine
May 2, 2022
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3 min read
FDA
MDA Celebrates FDA Approval of Alexion’s Ultomiris for Treatment of gMG
April 29, 2022
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4 min read
FDA
Supernus Announces FDA Approval of Qelbree® for the Treatment of ADHD in Adults
April 29, 2022
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6 min read
FDA
RINVOQ® (upadacitinib) Approved by U.S. FDA as an Oral Treatment for Adults with Active Ankylosing Spondylitis
April 29, 2022
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21 min read
Business
U.S. Food and Drug Administration Approves Camzyos (mavacamten) for the Treatment of Adults with Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM)
April 29, 2022
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5 min read
FDA
U.S. Food and Drug Administration Approves Camzyos™ (mavacamten) for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptoms
April 28, 2022
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20 min read
FDA
FDA Approves Mycovia Pharmaceuticals’ VIVJOA™ (oteseconazole), the First and Only FDA-Approved Medication for Recurrent Vulvovaginal Candidiasis (Chronic Yeast Infection)
April 28, 2022
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8 min read
FDA
Nevakar Injectables Receives U.S. FDA Approval of Ready-to-Use Ephedrine Injection in a Prefilled Syringe
April 28, 2022
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2 min read
FDA
Allogene Therapeutics Receives FDA Orphan-Drug Designation for ALLO-605, its First TurboCAR™ T Cell Product Candidate, for the Treatment of Multiple Myeloma
April 27, 2022
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5 min read
FDA
Gamida Cell Announces FDA Clearance of IND and Removal of Clinical Hold for NK Cell Therapy Candidate GDA-201
April 26, 2022
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6 min read
FDA
Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children
April 25, 2022
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3 min read
FDA
FDA Approves TLANDO® (testosterone undecanoate), an Oral Treatment for Testosterone Replacement Therapy by Antares Pharma, Inc., developed by Lipocine Inc.
April 25, 2022
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1 min read
FDA
Quoin Pharmaceuticals Announces FDA Clearance of IND for its Lead Asset, QRX003, for Netherton SyndromeQuoin Will Initiate Clinical Testing in 1H 2022
April 25, 2022
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3 min read
FDA
Intra-Cellular Therapies Announces FDA Approval of New Dosage Strengths for CAPLYTA® (lumateperone) for Specific Patient Populations
April 25, 2022
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9 min read
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