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Approvals

Policy
Biopharma Update on the Novel Coronavirus: May 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 21, 2020.
May 21, 2020
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4 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 20, 2020.
May 20, 2020
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6 min read
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BioSpace Editorial Staff
FDA
Lynparza Becomes Second PARP Inhibitor Approved for Prostate Cancer, Just Days Behind the First
Clovis Oncology’s Rubraca remained the only PARP inhibitor approved for prostate cancer for only a handful of days. Today, that medication is joined by AstraZeneca’s and Merck’s powerhouse PARP inhibitor, Lynparza.
May 20, 2020
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3 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: May 19
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 19, 2020.
May 19, 2020
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4 min read
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BioSpace Editorial Staff
FDA
FDA Grants Genentech’s Checkpoint Inhibitor Tecentriq Another NSCLC Approval
The approval was based on interim analysis from the company’s Phase III IMpower110 trial.
May 19, 2020
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2 min read
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Mark Terry
FDA
Clovis Oncology’s PARP Inhibitor Rubraca Gets Greenlight from FDA in Prostate Cancer
With the new approval, Rubraca becomes the first PARP inhibitor approved in a prostate cancer setting.
May 18, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: May 18
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 18, 2020.
May 18, 2020
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5 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 15, 2020.
May 15, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 14, 2020.
May 14, 2020
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3 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: May 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 13, 2020.
May 13, 2020
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3 min read
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BioSpace Editorial Staff
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PRESS RELEASES
FDA
Senseonics Announces FDA Approval of the Eversense® E3 Continuous Glucose Monitoring System for Use for Up to 6 months; Provides 2022 Business Outlook
February 11, 2022
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8 min read
FDA
Esaote North America announces a new gold standard in Open MRI with the FDA approved Magnifico™ Open MRI system.
February 10, 2022
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2 min read
FDA
Medovate Announces Exclusive US Distribution Agreement with Mercury Medical(R) for SAFIRA(R)
February 9, 2022
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4 min read
FDA
FDA Awards QIDP Designation for Prevention of Chlamydia to Evofem Biosciences
February 9, 2022
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4 min read
FDA
Leqvio® Therapy to Lower Cholesterol Approved by FDA, IVX Health Now Accepting New Leqvio Patients
February 8, 2022
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2 min read
FDA
Dose Reduction Capability of CARESTREAM Smart Noise Cancellation Receives FDA 510(k) Clearance
February 8, 2022
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3 min read
FDA
Eureka Therapeutics Receives Orphan Drug Designations for Treatment of Hepatocellular Carcinoma (HCC) With ARTEMIS® T Cells
February 8, 2022
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3 min read
FDA
CereVasc Receives FDA IDE Approval to Begin Initial Clinical Study of the eShunt® System for Patients with Normal Pressure Hydrocephalus
February 8, 2022
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2 min read
FDA
FDA Approves JUVÉDERM® VOLBELLA® XC For Undereye Hollows
February 8, 2022
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15 min read
FDA
Synthetic Biologics Announces VCN Biosciences’ VCN-01 Receives Orphan Drug Designation for Retinoblastoma from the U.S. FDA
February 8, 2022
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6 min read
FDA
atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial
February 8, 2022
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3 min read
FDA
Check-Cap Announces FDA Approval of Amended IDE Application for Pivotal Study of C-Scan
February 7, 2022
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4 min read
FDA
NGM Bio’s NGM621 Receives Fast Track Designation from the FDA for the Treatment of Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration
February 7, 2022
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8 min read
FDA
AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF FLEQSUVY™ (baclofen oral suspension)
February 7, 2022
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3 min read
FDA
FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease
February 4, 2022
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8 min read
FDA
Ambu Announces FDA Clearance of Single-Use Gastroscope and Next-Generation Display Unit
February 4, 2022
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4 min read
FDA
Clinical Trial Research at Wolfe Eye Clinic contributes to FDA Approval of Genentech’s Vabysmo ™, the First Bispecific Antibody for the Eye, Treating Two Vision Loss Causes
February 3, 2022
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4 min read
FDA
Viatris is First to Receive FDA Approval of Generic Restasis® (Cyclosporine Ophthalmic Emulsion 0.05%) to Treat Dry Eye Disease
February 3, 2022
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5 min read
FDA
BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure
February 3, 2022
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8 min read
FDA
Syros Receives FDA Orphan Drug Designation for Tamibarotene for the Treatment of MDS
February 2, 2022
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5 min read
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