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WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) recently completed its U.S. application for approval of QTORIN™ rapamycin to treat microcystic lymphatic malformations, putting the Wayne-based biotechnology company on a …
ICYMI: Palvella Seeks FDA Approval for Rare-Disease Skin Therapy Read More WAYNE, PA — Palvella Therapeutics Inc. (Nasdaq: PVLA) has completed its application for U.S. approval of QTORIN 3.9% rapamycin anhydrous gel to treat microcystic lymphatic malformations, moving the Wayne-based biotechnology …
Palvella Files FDA Bid for QTORIN Rapamycin in Rare Disease Read More WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) began its rolling U.S. application for QTORIN rapamycin during the second quarter as higher clinical, manufacturing and regulatory spending more than doubled …
Palvella Advances FDA Filing as Drug Spending Lifts Loss Read More WAYNE, PA — Palvella Therapeutics (Nasdaq: PVLA) has received U.S. Food and Drug Administration authorization for rolling review of its New Drug Application for QTORIN rapamycin, a step that could …
Palvella Secures FDA Rolling Review for Rare Disease Drug Read More WAYNE, PA — Palvella Therapeutics Inc. (Nasdaq: PVLA) said it remains on track to submit a New Drug Application in the second half of 2026 for its lead therapy targeting …
Palvella Advances Rare Disease Drug Toward FDA Filing Read More WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) said it remains on track to submit a New Drug Application in the second half of 2026 for QTORIN rapamycin after reporting …
Palvella Eyes 2027 Launch After Positive Phase 3 Results Read More
RADNOR, PA — Mineralys Therapeutics Inc. (Nasdaq: MLYS) reported its fourth-quarter and full-year 2025 financial results and said the U.S. Food and Drug Administration has accepted its new drug application …
Mineralys Reports 2025 Results, Advances Hypertension Drug Review Read More WAYNE, PA — Palvella Therapeutics Inc. (Nasdaq: PVLA) said it achieved the primary and all secondary endpoints in a Phase 3 trial of QTORIN 3.9% rapamycin gel for microcystic lymphatic …
Palvella Reports Phase 3 Success for QTORIN in Rare Skin Disorder Read More
MALVERN, PA — NexEos Bio Vision Health said that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to begin a Phase II/III clinical trial of …
NexEos Bio Vision Health Wins FDA Clearance for NTX-1024 Trial Read More
WILMINGTON, DE — Prelude Therapeutics Incorporated (Nasdaq: PRLD) said the U.S. Food and Drug Administration has cleared its investigational new drug application for PRT12396, allowing the company to begin a …
FDA Clears Prelude’s Experimental Cancer Drug, Opening New Path for Blood Disorders Read More