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LEO Pharma's FDA Acceptance for ANZUPGO Cream for Pediatric Eczema

LEO Pharma's FDA Acceptance for ANZUPGO Cream for Pediatric Eczema

LEO Pharma has announced the FDA's acceptance of its supplemental New Drug Application for ANZUPGO cream, aimed at treating chronic hand eczema in children aged 12-17. The cream, a non-steroidal pan-Janus kinase inhibitor, is already approved for adults with moderate to severe chronic hand eczema. If approved for pediatric use, ANZUPGO would be the first treatment specifically indicated for this age group, addressing a significant unmet medical need. The application is supported by positive data from the Phase 3 DELTA TEEN trial.
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LEO Pharma's ANZUPGO Cream Receives FDA Acceptance for Pediatric Eczema Treatment

LEO Pharma's ANZUPGO Cream Receives FDA Acceptance for Pediatric Eczema Treatment

LEO Pharma's ANZUPGO Cream Receives FDA Acceptance for Pediatric Eczema Treatment
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FDA Accepts LEO Pharma's Application for Pediatric Eczema Treatment

FDA Accepts LEO Pharma's Application for Pediatric Eczema Treatment

FDA Accepts LEO Pharma's Application for Pediatric Eczema Treatment
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Revolution Medicines Reports Positive Phase 3 Results for Pancreatic Cancer Treatment, Boosting Market Value

Revolution Medicines Reports Positive Phase 3 Results for Pancreatic Cancer Treatment, Boosting Market Value

Revolution Medicines Reports Positive Phase 3 Results for Pancreatic Cancer Treatment, Boosting Market Value
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Unapproved Weight-Loss Drug Retatrutide Gains Attention Despite FDA Status

Unapproved Weight-Loss Drug Retatrutide Gains Attention Despite FDA Status

Unapproved Weight-Loss Drug Retatrutide Gains Attention Despite FDA Status
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FDA Requests Additional Safety Data for Eli Lilly’s New Obesity Drug Foundayo

FDA Requests Additional Safety Data for Eli Lilly’s New Obesity Drug Foundayo

FDA Requests Additional Safety Data for Eli Lilly’s New Obesity Drug Foundayo
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FDA Grants RMAT Designation to Grace Science's Gene Therapy for NGLY1 Deficiency

FDA Grants RMAT Designation to Grace Science's Gene Therapy for NGLY1 Deficiency

FDA Grants RMAT Designation to Grace Science's Gene Therapy for NGLY1 Deficiency
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Corcept Therapeutics Presents Data from ROSELLA Trial: Improved Survival for Ovarian Cancer Patients

Corcept Therapeutics Presents Data from ROSELLA Trial: Improved Survival for Ovarian Cancer Patients

Corcept Therapeutics has presented final data from its Phase 3 ROSELLA trial, demonstrating that the combination of Lifyorli (relacorilant) and nab-paclitaxel significantly improves overall survival in patients with platinum-resistant ovarian cancer. The trial results, presented at the Society of Gynecologic Oncology's Annual Meeting and published in The Lancet, show a 35% reduction in the risk of death for patients receiving the combination therapy compared to nab-paclitaxel alone. The FDA approved Lifyorli in March 2026, marking it as the first selective glucocorticoid receptor antagonist for this patient group. The treatment has been added to the National Comprehensive Cancer Network's guidelines as a preferred regimen.
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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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Revolution Medicines' Pancreatic Cancer Drug Daraxonrasib Shows Promising Results in Phase 3 Trial

Revolution Medicines' Pancreatic Cancer Drug Daraxonrasib Shows Promising Results in Phase 3 Trial

Revolution Medicines has announced successful results from a Phase 3 trial of its pancreatic cancer drug, daraxonrasib. The trial demonstrated that the drug nearly doubled the typical length of survival for patients and reduced the risk of death by 60% compared to chemotherapy. Daraxonrasib targets RAS mutations, which are prevalent in pancreatic cancer cases. The company plans to seek FDA approval using a Commissioner's National Priority Voucher, which could expedite the review process. The drug's success in the trial marks a significant advancement in the treatment of pancreatic cancer, a disease known for its low survival rates.
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Eli Lilly Acquires CrossBridge Bio to Enhance Cancer Care with $300M Deal

Eli Lilly Acquires CrossBridge Bio to Enhance Cancer Care with $300M Deal

Eli Lilly Acquires CrossBridge Bio to Enhance Cancer Care with $300M Deal
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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