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Accelerated approval

Regulatory
Deep Dive: FDA’s Accelerated Approval Pathway Under Fire
In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.
November 18, 2024
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2 min read
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Heather McKenzie
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PRESS RELEASES
Press Releases
FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
April 24, 2026
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4 min read
Press Releases
Otarmeni™ (lunsotogene parvec-cwha) Approved by FDA as First and Only Gene Therapy for Genetic Hearing Loss; Regeneron to Provide Otarmeni for Free in the U.S.
April 24, 2026
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16 min read
Press Releases
Nurix Therapeutics Reports First Quarter 2026 Financial Results and Provides a Corporate Update
April 8, 2026
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12 min read
Press Releases
Rocket Pharmaceuticals Announces FDA Approval of KRESLADI™ for Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I)
March 27, 2026
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12 min read
Press Releases
Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
March 25, 2026
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17 min read
Press Releases
FDA Approves Once-Weekly YUVIWEL® (navepegritide) for Children with Achondroplasia Aged 2 Years and Older
March 2, 2026
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11 min read
Press Releases
FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option
February 26, 2026
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12 min read
Press Releases
U.S. FDA Grants Full Approval to Pfizer’s BRAFTOVI Combination Regimen in First-Line Metastatic Colorectal Cancer
February 25, 2026
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20 min read
Press Releases
Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP
February 15, 2026
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7 min read
Press Releases
Novartis Vanrafia® Phase III data support slowing of kidney function decline in patients with IgA nephropathy
February 13, 2026
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9 min read
Press Releases
Guardant Health Receives FDA Approval for Guardant360® CDx as Companion Diagnostic for BRAFTOVI® (encorafenib) Combination in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer
January 23, 2026
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5 min read
Press Releases
Saudi FDA Grants Accelerated Approval to ImmunityBio’s ANKTIVA® for Non-Muscle Invasive Bladder Cancer with Carcinoma In-Situ
January 15, 2026
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8 min read
Press Releases
FDA Accepts for Review INOVIO’s BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP)
December 29, 2025
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8 min read
Press Releases
FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma
December 22, 2025
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16 min read
Press Releases
FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma
December 22, 2025
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8 min read
Press Releases
Sangamo Therapeutics Initiates Rolling Submission of BLA to U.S. FDA for ST-920 in Fabry Disease
December 19, 2025
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6 min read
Press Releases
Palvella Therapeutics Granted FDA Fast Track Designation for QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Angiokeratomas
December 16, 2025
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7 min read
Press Releases
Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)
December 4, 2025
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5 min read
Press Releases
U.S. FDA approves expanded indication for Lilly’s Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, for adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor
December 4, 2025
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17 min read
Press Releases
Otsuka Receives FDA Accelerated Approval for VOYXACT® (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression
November 26, 2025
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13 min read
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