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PolyPid to Present Phase 3 SHIELD II Data on D-PLEX100 at ESCMID Global 2026

PolyPid to Present Phase 3 SHIELD II Data on D-PLEX100 at ESCMID Global 2026

PolyPid to Present Phase 3 SHIELD II Data on D-PLEX100 at ESCMID Global 2026
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PolyPid Presents Phase 3 Data on D-PLEX100 at ESCMID Global 2026

PolyPid Presents Phase 3 Data on D-PLEX100 at ESCMID Global 2026

PolyPid Presents Phase 3 Data on D-PLEX100 at ESCMID Global 2026
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FDA Grants Priority Review to Ifinatamab Deruxtecan for Small Cell Lung Cancer Treatment

FDA Grants Priority Review to Ifinatamab Deruxtecan for Small Cell Lung Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for ifinatamab deruxtecan, a potential first-in-class B7-H3 directed DXd antibody drug conjugate developed by Daiichi Sankyo and Merck. This investigational drug is intended for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following platinum-based chemotherapy. The Priority Review status indicates that the FDA sees significant potential for the drug to improve treatment outcomes compared to existing options. The application is also being reviewed under the Real-Time Oncology Review (RTOR) program and Project Orbis, which aim to expedite the availability of effective cancer treatments. The Prescription Drug User Fee Act (PDUFA) date for the FDA's decision is set for October 10, 2026.
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FDA's Second Rejection of Replimune's Melanoma Drug RP1 Sparks Strategic Overhaul

FDA's Second Rejection of Replimune's Melanoma Drug RP1 Sparks Strategic Overhaul

FDA's Second Rejection of Replimune's Melanoma Drug RP1 Sparks Strategic Overhaul
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FDA Grants Full Approval to Travere Therapeutics' Filspari for Rare Kidney Disease FSGS

FDA Grants Full Approval to Travere Therapeutics' Filspari for Rare Kidney Disease FSGS

FDA Grants Full Approval to Travere Therapeutics' Filspari for Rare Kidney Disease FSGS
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FDA Approves Travere Therapeutics' FILSPARI for Rare Kidney Disease FSGS

FDA Approves Travere Therapeutics' FILSPARI for Rare Kidney Disease FSGS

FDA Approves Travere Therapeutics' FILSPARI for Rare Kidney Disease FSGS
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Replimune Faces Challenges After Second FDA Rejection of Melanoma Drug

Replimune Faces Challenges After Second FDA Rejection of Melanoma Drug

Replimune Faces Challenges After Second FDA Rejection of Melanoma Drug
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FDA Introduces New Draft Safety Guidelines to Accelerate Gene Therapy Development

FDA Introduces New Draft Safety Guidelines to Accelerate Gene Therapy Development

The U.S. Food and Drug Administration (FDA) has released new draft guidance aimed at standardizing safety evaluations for genome editing therapies. This initiative is part of the FDA's efforts to expedite the development of personalized gene therapies, particularly for ultra-rare diseases. The guidance focuses on next-generation sequencing techniques to identify unintended consequences of gene therapies. It builds on previous guidance from 2024 and includes recommendations for nonclinical studies related to investigational new drug and biologics license applications. The FDA is seeking public comments on this draft, which is part of a broader strategy to formalize the development of bespoke therapies, such as the first custom CRISPR therapy for a child with a rare metabolic condition.
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FDA Urges Over 2,200 Sponsors to Disclose Clinical Trial Results, Addresses Publication Bias

FDA Urges Over 2,200 Sponsors to Disclose Clinical Trial Results, Addresses Publication Bias

The U.S. Food and Drug Administration (FDA) has reminded more than 2,200 medical product companies and researchers to submit clinical trial results to ClinicalTrials.gov. The agency highlights the issue of publication bias, where negative trial results are often not disclosed, leading to a skewed perception of drug efficacy and safety. The FDA's initiative aims to ensure transparency and improve public access to clinical data. The agency has sent messages to companies and researchers to encourage voluntary compliance with reporting requirements, emphasizing the ethical obligation to disclose all trial outcomes.
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FDA Introduces New Draft Safety Guidelines to Accelerate Bespoke Gene Therapies

FDA Introduces New Draft Safety Guidelines to Accelerate Bespoke Gene Therapies

The FDA has released new draft guidance aimed at standardizing safety evaluations for genome editing therapies. This initiative is part of a broader effort to expedite the development of personalized treatments for ultra-rare diseases. The guidance, issued by the FDA’s Center for Biologics Evaluation and Research, builds on previous guidelines from 2024 and focuses on both ex vivo and in vivo products. It includes recommendations for sequencing strategies and analysis parameters to ensure comprehensive safety assessments. The FDA is seeking public comments on these guidelines, which are designed to support nonclinical studies accompanying investigational new drug and biologics license applications. This move follows the FDA's earlier announcement of a new pathway to accelerate bespoke therapies, exemplified by the creation of a custom CRISPR therapy for a child with a rare metabolic condition.
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Verley Innovates Sports Nutrition with Precision Fermentation for Protein Efficiency

Verley Innovates Sports Nutrition with Precision Fermentation for Protein Efficiency

Verley Innovates Sports Nutrition with Precision Fermentation for Protein Efficiency
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FDA's Transparency Policy on Complete Response Letters Enhances Biopharma Accountability

FDA's Transparency Policy on Complete Response Letters Enhances Biopharma Accountability

FDA's Transparency Policy on Complete Response Letters Enhances Biopharma Accountability