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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
C-Path Reaffirms Commitment to Advancing Regulatory Science for Disease-Modifying Therapies in Type 1 Diabetes
June 16, 2026
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5 min read
Press Releases
Press Release: Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes
June 14, 2026
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9 min read
Press Releases
Lupeng Pharmaceutical’s Fourth-Generation BTK Inhibitor Rocbrutinib Approved in China for Relapsed or Refractory Mantle Cell Lymphoma
June 4, 2026
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6 min read
Press Releases
Vertex Announces US FDA Acceptance of Biologics License Application for Accelerated Approval of Povetacicept in IgA Nephropathy
June 2, 2026
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8 min read
Press Releases
Dizal’s ZEGFROVY® (Sunvozertinib) New Drug Application Accepted and Granted Priority Review by China National Medical Products Administration for First-Line Treatment of EGFR Exon 20 Insertion-Mutated Non-Small Cell Lung Cancer
May 27, 2026
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5 min read
Press Releases
Orsini to Serve as Contracted Specialty Pharmacy for Gilead’s Hepcludex® (bulevirtide‑gmod)
May 26, 2026
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2 min read
Press Releases
FDA Grants Accelerated Approval to Gilead’s Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV)
May 24, 2026
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10 min read
Press Releases
Dyne Therapeutics Announces Initiation of Phase 3 FORZETTO Trial of Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD) Ahead of Planned BLA Submission for U.S. Accelerated Approval
May 20, 2026
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10 min read
Press Releases
BeOne Medicines’ BEQALZI™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma
May 14, 2026
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10 min read
Press Releases
Agios Submits sNDA to FDA for U.S. Accelerated Approval of Mitapivat in Sickle Cell Disease
May 12, 2026
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10 min read
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
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