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Approvals

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
FDA approved Ascendis Pharma’s Skytrofa.
FDA
Report: NDA, BLA Approvals by the FDA Fell 16% in 2019
A new report released on Tuesday by GlobalData suggested that there was a 16% decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration last year.
May 12, 2020
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2 min read
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Krystle Vermes
Drug Development
Biopharma Update on the Novel Coronavirus: May 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 12, 2020.
May 12, 2020
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3 min read
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BioSpace Editorial Staff
FDA
Abbott Earns Emergency Use Authorization for Another COVID-19 Antibody Test
Approval of Abbott’s latest antibody test comes days after the FDA tightened its rules regarding the regulatory requirement for them.
May 11, 2020
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2 min read
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Alex Keown
TARPEYO is the first FDA-approved drug for immunog
FDA
AstraZeneca and Merck’s Lynparza Approved For Ovarian Cancer Just a Week After GSK’s Zejula
The Lynparza approval isn’t as broad as the Zejula approval, with Lynparza not approved for use in patients with homologous recombination deficiencies.
May 11, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 11
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 11, 2020.
May 11, 2020
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4 min read
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BioSpace Editorial Staff
Jonathan Weiss/Shutterstock
FDA
FDA Approves Eli Lilly’s Precision Oncology Treatment Retevmo for Certain Lung and Thyroid Cancers
Eli Lilly is moving quickly to get a newly-approved precision oncology treatment, Retevmo, for certain lung and thyroid cancers into the hands of patients.
May 11, 2020
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3 min read
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Alex Keown
FDA
FDA Grants Emergency Use Authorization for Rutgers’ At-Home COVID-19 Saliva Test
The new at-home saliva self-collection assay allows for broader screening than the standard and uncomfortable method using nose and throat swabs at a healthcare facility or testing location that requires a physical interaction with a healthcare professional.
May 8, 2020
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2 min read
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Alex Keown
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PRESS RELEASES
Press Releases
FDA Grants Seventh Approval under the National Priority Voucher Pilot Program
May 10, 2026
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2 min read
Press Releases
argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG
May 10, 2026
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14 min read
Press Releases
Alpha Tau Completes Patient Enrollment in its U.S. Pivotal Skin Cancer Study, Advancing Towards Goal of FDA Approval of Alpha DaRT® to Treat Recurrent Cutaneous Squamous Cell Carcinoma
May 8, 2026
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9 min read
Press Releases
Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib) for the Treatment of Active Psoriatic Arthritis in Adults
May 8, 2026
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18 min read
Press Releases
InnoCare Announces Approval of a Phase II Clinical Trial of TYK2 Inhibitor ICP-488 for Sjögren’s Syndrome in China
May 8, 2026
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3 min read
Press Releases
Aspire Biopharma Holdings, Inc. Announces Approval Of Reverse Stock Split Ratio
May 7, 2026
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4 min read
Press Releases
Scienture Secures $11.0 Million in Non-Dilutive Debt Financing to Accelerate Growth of Approved Product Portfolio and Advancement of R&D Pipeline
May 7, 2026
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11 min read
Press Releases
InnoCare Announces Approval of Clinical Trial of Novel CDH7 targeted ADC ICP-B208 in China
May 7, 2026
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3 min read
Press Releases
Avacta presents new comparisons of pre|CISION® payload release vs approved ADCs and AVA6207 dual payload delivery at Science Day 2026
May 6, 2026
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5 min read
Press Releases
Lannett Company, Lanexa Biologics and Sunshine Lake Pharma announce FDA Approval of LANGLARA™ an Interchangeable Biosimilar of Lantus® (insulin glargine)
May 4, 2026
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5 min read
Press Releases
Caris Life Sciences Receives MolDX Approval for Caris ChromoSeq, Advancing Access to Comprehensive Genomic Profiling for Myeloid Malignancies
May 4, 2026
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6 min read
Press Releases
Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 Mutations
May 4, 2026
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4 min read
Press Releases
ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIV™ to Include Pediatric Immune Compromised Patients Two Years of Age and Older
May 4, 2026
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6 min read
Press Releases
Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease
May 4, 2026
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14 min read
Press Releases
InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System
May 4, 2026
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6 min read
Press Releases
Apotex becomes the first Canadian‑based pharmaceutical company to receive Health Canada approval for a generic equivalent of Ozempic®
May 4, 2026
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3 min read
Press Releases
Novartis receives Health Canada approval for Fabhalta® oral treatment for adults with C3G
May 4, 2026
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4 min read
Press Releases
Arvinas Announces FDA Approval of VEPPANU (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer
May 3, 2026
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13 min read
Press Releases
Arrowhead Pharmaceuticals Receives TGA Approval of REDEMPLO® (plozasiran) in Australia, Expanding Global Access for Patients with Familial Chylomicronemia Syndrome (FCS)
May 1, 2026
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10 min read
Press Releases
Axsome Therapeutics Hosts AUVELITY® FDA Approval Investor Event Featuring Expert Thought Leader
May 1, 2026
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15 min read
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