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Approvals

Policy
Biopharma Update on the Novel Coronavirus: July 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 3, 2020.
July 2, 2020
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1 min read
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BioSpace Editorial Staff
FDA gave green signal to Beigene's Brukinsa after
FDA
FDA Gives Pfizer and Merck KGaA’s Bavencio a Thumbs-Up for Urothelial Cancer
Bavencio is an anti-PD-L1 checkpoint inhibitor co-developed by Merck KGaA, Darmstadt, German and Pfizer via EMD Serono, a business unit of the two companies.
July 1, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: July 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 1, 2020.
June 30, 2020
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3 min read
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BioSpace Editorial Staff
FDA
Merck’s Keytruda Approved for First-Line Treatment of Colorectal Cancer
The anti-PD-1 therapy was approved by the U.S. Food and Drug Administration alone for first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
June 30, 2020
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3 min read
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Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: June 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 29, 2020.
June 29, 2020
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2 min read
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BioSpace Editorial Staff
Abicipar pegol rejected by FDA
FDA
Allergan/AbbVie’s Macular Degeneration Drug Abicipar Pegol Rejected by FDA
The U.S. Food and Drug Administration issued a Complete Response Letter, a rejection, of Allergan’s Biologics License Application for Abicipar pegol for neovascular age-related macular degeneration.
June 26, 2020
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3 min read
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Mark Terry
FDA
Zogenix Wins Approval for Dravet Syndrome Treatment Fintepla
Shares of Zogenix were up more than 16% in premarket trading following the regulatory approval of the epilepsy drug Fintepla for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy, in patients ages two and above.
June 26, 2020
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2 min read
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Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 26, 2020.
June 25, 2020
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3 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: June 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 24, 2020.
June 23, 2020
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4 min read
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BioSpace Editorial Staff
FDA
Karyopharm’s Xpovio Wins Second FDA Approval for DLBCL Treatment
The U.S. Food and Drug Administration greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
June 23, 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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