FDA & Clinical Trials
Radiopharm Schedules FDA Meeting on RAD101 Phase 3 Trial Design
Radiopharm Theranostics Limited (Nasdaq: RADX; ASX: RAD) says it has scheduled an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for October 1, 2026. The company plans to discuss the pivotal Phase 3 trial design for RAD101, its investigational imaging agent for suspected recurrent brain metastases following radiotherapy. The meeting is expected to…
What Is a REMS Program? The FDA’s Safety Tool for High-Risk Drugs
Not every FDA approval comes free of ongoing obligations. For drugs carrying serious risks — where the benefit still outweighs the risk, but only if specific precautions are followed — the FDA can require a Risk Evaluation and Mitigation Strategy, commonly known as a REMS. A REMS program can materially affect how a drug is…
ArkBio Wins China IND Clearance for Flu Antiviral AK0406
Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announced on August 12 that China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for AK0406, an injectable candidate the company describes as, in its words, the first influenza antiviral drug-Fc conjugate to enter clinical development in China. ArkBio is privately held and does…
Viatris Wins FDA Approval for Gwyn Lo Contraceptive Patch
Viatris Inc. (Nasdaq: VTRS) announced on July 29 that the FDA has approved Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system), a new once-weekly contraceptive patch delivering a lower dose of estrogen than some existing patch options. The approval covers women with a body mass index below 30 kg/m squared who are appropriate candidates for…
RiboX Enters Crowded In Vivo CAR-T Field With FDA IND Nod
RiboX Therapeutics Ltd., a private, clinical-stage biotechnology company with operations in China, the U.S., and Israel, announced on August 8 that the FDA has cleared its Investigational New Drug (IND) application for RXIM002, clearing the way for a Phase 1 trial of what the company describes as the first circular RNA-based in vivo CAR-T therapy…
What Is Adaptive Trial Design? A More Flexible Approach to Clinical Trials
Traditional clinical trials are locked in from the start — the protocol, sample size, and statistical plan are fixed before the first patient enrolls, and they remain unchanged regardless of what the accumulating data shows until the study is complete. Adaptive trial design offers an alternative: a framework that allows specific, pre-planned modifications to a…
Inside the inMIND Trial Data Behind Minjuvi’s New PBS Listing
Specialised Therapeutics (ST), a Singapore-headquartered specialty pharmaceutical company, announced in a press release on August 2 that Minjuvi (tafasitamab), used together with rituximab and lenalidomide, is now reimbursed under Australia’s Pharmaceutical Benefits Scheme (PBS) for adults with relapsed or refractory follicular lymphoma (R/R FL). For patients, the listing means government-subsidized access to a chemotherapy-free treatment…
What Is Real-World Evidence? How Data Outside Clinical Trials Is Reshaping FDA Decisions
For decades, the randomized controlled clinical trial was the only currency the FDA accepted as proof of a drug’s safety and efficacy. That is changing. Real-world evidence — data generated outside the traditional clinical trial setting, from sources like electronic health records, insurance claims, and patient registries — is increasingly being used to support FDA…
What Is a Clinical Hold? When the FDA Stops a Trial and What Happens Next
Few announcements strike more fear into biotech investors than a clinical hold. When the FDA issues a clinical hold on a company’s Investigational New Drug application, it means the agency has identified concerns serious enough to stop human testing — either entirely or in part. Stocks frequently fall 30% to 60% or more on clinical…
What Is Fast Track Designation? The FDA’s Most Common Expedited Program Explained
Of all the FDA expedited designations a biotech company can receive, Fast Track Designation is the most commonly granted and, as a result, the least dramatic in terms of immediate stock impact. Yet it is one of the most practically useful regulatory tools available to drug developers, and understanding what it does — and critically,…
