The Manila Times

Opus Genetics Announces FDA Alignment on Phase 3 Registrational Trial Design for OPGx-LCA5 in LCA5-Associated Inherited Retinal Disease

Opus Genetics, Inc. (Nasdaq: IRD) (the "Company” or "Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

FDA launches pilot program to speed up early drug trials

The agency says pairing drug sponsors with research institutions could cut development timelines by 6 to 12 months ...
RAPS

FDA, industry discuss need for flexibility in early phase clinical development of cell therapy products

Left to right: Lola Fashoyin-Aje, Steven Fleischer, Vijay Kumar, Travis Quigley, Rosanna Ricafort, Nirali N. Shah, and Chris White. (Source: FOCR) More flexibility in early-phase development for cell ...
The Scientist

Understanding the Drug Development Process

This Brush Up is sponsored by MilliporeSigma. Learn more about therapeutic synthesis pathways. Drug development is a process that spans many years, from the initial phase of identifying potential drug ...
Seeking Alpha

UniQure outlines next steps for Huntington’s program as FDA recommends Phase III sham-controlled trial

CEO Matthew Kapusta opened the call by emphasizing uniQure’s enduring focus on advancing gene therapies, highlighting "groundbreaking 3-year data from our Phase I/II study of AMT-130," which ...
Business Wire

Prilenia and Ferrer Announce FDA Clearance to Start the “PREVAiLS” Pivotal Phase 3 Study with Pridopidine in ALS

FDA clearance received to start the pivotal, 500-patient, placebo-controlled Phase 3 “PREVAiLS” study of pridopidine in participants with early, rapidly progressive ALS; US recruitment set to begin ...
Nasdaq

Intellia Announces FDA Lift Of Clinical Hold On MAGNITUDE-2 Phase 3 Trial In ATTRv-PN

(RTTNews) - Intellia Therapeutics, Inc. (NTLA) announced that the U.S. FDA has lifted the clinical hold on its MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran (nex-z) in hereditary ...
JD Supra

HHS “Operation TrialBlazer”: FDA Moves to Accelerate and Modernize Clinical Development

On June 22, 2026, the U.S. Department of Health and Human Services (HHS) announced the launch of Operation TrialBlazer, a coordinated effort ...
Morningstar

Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components

61% overall MMR and 48% MMR achievement by 24 weeks in the 80 mg QD Phase 1b cohort 67% overall MMR and 55% MMR achievement by 24 weeks in all Phase 1b patients who had previously received 1 or 2 ...