pharmaphorum6d
Challenges and opportunities in global clinical trials
faster timelines, and increased patient populations. In particular, global clinical trials can potentially lead to simultaneous launches of new medical products in multiple regions across the ...
NeuroOne® Accelerates Timeline of 510(k) Submission to FDA for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain
Submission for New Intended Use That Leverages Company’s Patented OneRF® Technology Platform Expected in May 2025 EDEN PRAIRIE, Minn., March 11, ...
MBX Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Highlights
Enrollment complete in Phase 2 Avail™ trial of canvuparatide in hypoparathyroidism; topline results on track for Q3 2025MBX 1416 Phase 2 trial in ...
pharmaphorum5d
The changing environment for pharma and medtech companies in Europe
The EU clinical trials law is currently up for revision ... via EU portal • Risk-based assessment approach • Clear timelines with tacit approval mechanisms (if authorities have not reacted ...
Trump Administration Highlights: Schumer Says Enough Democrats Will Vote to Avert Government Shutdown
Senator Chuck Schumer of New York, the Democratic leader, broke with his party on Thursday and said he would vote for a ...
Sagimet Biosciences Inc.: Sagimet Biosciences Announces Clearance of IND for FASN Inhibitor TVB-3567, to be Developed for the Treatment of Acne
TVB-3567 is the Company's second fatty acid synthase (FASN) inhibitor First-in-human Phase 1 trial initiation planned in 2025 SAN MATEO, Calif., March 11, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences ...
ProQR Therapeutics N.V.: ProQR Announces Year End 2024 Operating and Financial Results
Axiomer ADAR-mediated RNA editing pipeline advancing across liver and CNS programs, with CTA filing on track for Q2 2025 for lead program AX-0810 targeting NTCP for Cholestatic diseases Company expect ...
The Manila Times5d
Medera Completes Patient Dosing in Phase 1/2a MUSIC-HFrEF Trial of SRD-001 Gene Therapy for Heart Failure with Reduced Ejection Fraction
Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via ...
Business Wire5d
Geron Announces European Commission Approval of RYTELO® (imetelstat), a First-in-Class Telomerase Inhibitor, for the Treatment of Adults With Transfusion-Dependent Anemia Due ...
Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today an ...
Taiwan News3d
ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label
Nikhil Lalwani, President and CEO of ANI stated, “ILUVIEN’s expanded label and the strengthening of our partnership with long-standing ILUVIEN contract manufacturer, Seigfried, will enhance supply ...
JD Supra2d
Closing the Gap: Why Women’s Health Is Still Underfunded—And How to Bring About Change
During the week of the 2025 J.P. Morgan Healthcare Conference in San Francisco, life sciences partners Suzanne Filippi and Laurie Burlingame led ...
New data capture laws since 1849 governing minors' legal capacity to consent to sexual health services
A new dataset captures more than 170 years of US state laws governing minors' legal capacity to independently consent to ...