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WASHINGTON, D.C. — The Department of Veterans Affairs and the Department of Health and Human Services signed an agreement to coordinate research and regulatory efforts aimed at accelerating the evaluation …
VA, HHS Expand Psychedelic Research for Veterans Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) plans to test its Teverelix drug candidate in about 126 patients after receiving FDA feedback and central ethics approval for a redesigned …
Medicus Cuts Planned Teverelix Trial Enrollment by Two-Thirds Read More
WAYNE, PA — Clinical trial sponsors using risk-based quality management (RBQM) may shorten oncology trial timelines by as much as 19% while generating returns of up to 23 times their …
CluePoints Study Links Risk-Based Trial Oversight to Faster Drug Development Read More
MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) has completed enrollment in its pivotal Phase 3 Alzheimer’s disease trial, positioning the biotechnology company for two planned U.S. regulatory submissions beginning …
Annovis Completes Enrollment for Alzheimer’s Phase 3 Trial Read More
BALA CYNWYD, PA — Larimar Therapeutics, Inc. has begun a rolling application for accelerated U.S. approval of its experimental Friedreich’s ataxia treatment, positioning the biotechnology company to potentially launch the …
Larimar Starts FDA Filing for FA Drug With Mid-2027 Goal Read More
COLLEGEVILLE, PA — Thubrikar Aortic Valve Inc. has entered an exclusive European distribution agreement with MAC’s MEDICAL Group that includes financing for up to 50 additional implants in the company’s …
Thubrikar Secures Europe Deal to Fund Valve Trial Expansion Read More
WAYNE, PA — Teleflex Inc. (NYSE: TFX) has begun enrolling patients in a global pivotal study of its Freesolve resorbable magnesium scaffold, advancing the company’s effort to bring a temporary …
Teleflex Launches Pivotal Trial for Resorbable Heart Scaffold Read More
WEST CHESTER, PA — Verrica Pharmaceuticals (Nasdaq: VRCA) has dosed the first U.S. patient in a second Phase 3 clinical trial evaluating YCANTH for common warts, expanding a late-stage development …
Verrica Advances Wart Treatment Program With Phase 3 Trial Expansion Read More
NEWTOWN, PA — Traws Pharma (NASDAQ: TRAW) said this week it is preparing additional toxicology data requested by U.K. regulators, delaying the planned launch of a Phase 2a human influenza …
Traws Pharma Delays Influenza Study as UK Regulator Seeks More Data Read More
WILMINGTON, DE — NRx Pharmaceuticals (Nasdaq: NRXP) said the U.S. Food and Drug Administration has authorized an Expanded Access Protocol for its investigational depression treatment NRX-101, potentially allowing certain patients …
FDA Clears Expanded Access Path for NRx Depression Therapy Read More