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Approvals

FDA
FDA Grants Gilead’s Remdesivir Emergency Use Authorization for COVID-19
The U.S. Food and Drug Administration (FDA) approved Gilead’s remdesivir under Emergency Use Authorization as a treatment for COVID-19 following reports the drug met its primary endpoint in a U.S. National Institute of Allergy and Infectious Diseases (NIAID) clinical trial.
May 1, 2020
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3 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: May 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 1, 2020.
May 1, 2020
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5 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 30
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 30, 2020.
April 30, 2020
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5 min read
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BioSpace Editorial Staff
Ovarian cancer vaccine under research.
FDA
FDA Approves GSK’s PARP Inhibitor Zejula for New Ovarian Cancer Indication
Zejula, GlaxoSmithKline’s once-daily PARP inhibitor, won regulatory approval as a monotherapy maintenance treatment for women with advanced ovarian cancer whose disease is responsive to first-line platinum-based chemotherapy, regardless of biomarker status.
April 30, 2020
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3 min read
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Alex Keown
Tada Images / Shutterstock
FDA
FDA Approves New 6-Week Dosing for Keytruda for All Approved Adult Indications
The U.S. Food and Drug Administration approved an additional recommended dosage of 400 mg every six weeks for the anti-PD-1 therapy across all adult indications, including as a monotherapy and in combination treatments.
April 29, 2020
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2 min read
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Alex Keown
FDA approved Ascendis Pharma’s Skytrofa.
FDA
Neurocrine Biosciences Receives FDA Approval for Ongentys, Opts to Delay Launch
Neurocrine Biosciences announced on Monday that it has received approval from the U.S. Food and Drug Administration for its once-daily oral drug, Ongentys, as an add-on treatment to levodopa/carbidopa for the treatment of Parkinson’s disease.
April 28, 2020
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3 min read
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Krystle Vermes
Policy
Biopharma Update on the Novel Coronavirus: April 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 28, 2020.
April 28, 2020
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6 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 27, 2020.
April 27, 2020
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7 min read
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BioSpace Editorial Staff
FDA
FDA Approves Sanofi’s Meningococcal Meningitis Vaccine
David Loew, head of Sanofi Pasteur, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours.
April 24, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: April 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 24, 2020.
April 24, 2020
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7 min read
 · 
BioSpace Editorial Staff
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PRESS RELEASES
Press Releases
Partner Therapeutics Announces FDA Approval of BIZENGRI® (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner’s National Priority Voucher
May 11, 2026
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12 min read
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
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