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Aardvark halts Phase III HERO after cardiac signals – program paused
Aardvark Therapeutics voluntarily paused dosing and enrollment in its Phase III HERO trial of ARD‑101 for hyperphagia in Prader‑Willi syndrome after routine safety monitoring in a healthy...
Roche wins Phase 3 in MS – liver‑safety signal clouds approval path
Roche reported another positive Phase 3 readout for its oral BTK inhibitor fenebrutinib in multiple sclerosis, clearing primary efficacy endpoints across indications. However, the study also...
FDA grants accelerated approval: Ascendis’ once‑weekly Yuviwel cleared for achondroplasia
The FDA granted accelerated approval to Ascendis Pharma’s once‑weekly TransCon CNP (now Yuviwel; navepegritide) for children aged two and older with achondroplasia, the most common form of...
Candid to go public via reverse merger – $505M backs T‑cell engager push
Candid Therapeutics will merge with Rallybio in a reverse merger to list on Nasdaq and has secured $505 million in private financing to advance its pipeline of bispecific T‑cell engagers (TCEs)....
Earendil taps WuXi XDC for ADC development – pact worth up to $885M
Earendil Labs signed a global license and development agreement with WuXi XDC to use WuXi’s payload‑linker and manufacturing platform for multiple antibody‑drug conjugate (ADC) programs, with...
Merck to end Gardasil runs at Durham plant – >150 jobs to be cut
Merck disclosed plans to stop producing Gardasil and Gardasil 9 at its Durham, North Carolina, facility and will lay off 147 workers tied to that operation, citing a worldwide reduction in demand...
FDA clears Delivery Date AI: De Novo nod for ultrasound‑based prediction software
The FDA granted De Novo clearance to Ultrasound AI’s cloud‑based Delivery Date AI software-as‑a‑medical‑device, allowing obstetric providers to use standard ultrasound images to predict delivery...
Universal newborn cCMV screening boosts early detection – Minnesota study shows gains
A retrospective cohort study from Minnesota found that mandated universal newborn screening for congenital cytomegalovirus (cCMV) substantially increased early detection rates and identified mild...
FDA Demands Sham-Controlled Trial – UniQure’s Huntington Path Stalls
The FDA has recommended a randomized, double-blind, sham surgery–controlled trial for uniQure’s AMT‑130 gene therapy program in Huntington’s disease, the company said after a recent regulator...
Aardvark Halts Phase III HERO Trial – Cardiac Signals Trigger Safety Pause
Aardvark Therapeutics voluntarily paused dosing and enrollment in its Phase III HERO trial of ARD‑101 for hyperphagia in Prader‑Willi syndrome after routine safety monitoring identified reversible...
Candid to Go Public Through Reverse Merger With Rallybio – $505M Backing
Candid Therapeutics agreed to a reverse merger with Rallybio to list on Nasdaq and raised $505 million in private financing to advance its bispecific T‑cell engager (TCE) portfolio. The deal...
FDA Lifts Clinical Hold on Intellia CRISPR Trials – New Safeguards Imposed
The FDA has lifted a clinical hold on Intellia’s Magnitude Phase 3 trial of in‑vivo CRISPR gene editing therapy nexiguran ziclumeran (nex‑z) in transthyretin amyloidosis with cardiomyopathy,...
Roche’s BTK Pill Clears Another Phase 3 — Safety Signal Complicates Approval Path
Roche reported a third positive Phase 3 trial for fenebrutinib in multiple sclerosis, meeting primary endpoints, but the studies revealed a concerning liver safety signal and an imbalance in...
Nanopore Momentum: Oxford Posts Revenue Gain as CHOP, Seattle Children’s Adopt Rapid Sequencing
Oxford Nanopore announced 22% full‑year 2025 revenue growth after a strategic restructuring that narrowed product focus and reduced some R&D headcount. The company said it is prioritizing...
Evinova Signs AI Pacts With Big Pharma to Benchmark and Speed Clinical Trials
Evinova, an AstraZeneca‑established AI‑native clinical development platform, signed agreements allowing Astellas, Bristol Myers Squibb and AstraZeneca to use its systems for study design...
Earendil Licenses WuXi Payload‑Linker Tech in Up‑to‑$885M ADC Deal
Earendil Labs signed a global license and development pact with WuXi XDC worth up to $885 million to use WuXi’s payload‑linker technology and CRDMO capabilities for antibody‑drug conjugate (ADC)...
FDA Accelerates Approval of Ascendis’ Yuviwel – New Challenger in Achondroplasia
The U.S. Food and Drug Administration granted accelerated approval to Ascendis Pharma’s TransCon CNP (now Yuviwel/navepegritide) for children two and older with achondroplasia, based on gains in...
Plasma mcfDNA Sequencing Predicts Bloodstream Infections Days Earlier in Pediatric Leukemia
Researchers at St. Jude Children’s Research Hospital published a Lancet Microbe study showing that plasma microbial cell‑free DNA sequencing (mcfDNA‑Seq) can detect bloodstream infections in...
UniQure blocked by FDA: sham‑surgery trial requested
The FDA has told uniQure that its current data package for AMT‑130, a gene therapy for Huntington’s disease, is not sufficient and recommended a prospective, randomized, double‑blind, sham...
FDA lifts hold on Intellia CRISPR trial – Magnitude restarts with caveats
The FDA has fully released a clinical hold on Intellia’s Phase 3 Magnitude trial testing its CRISPR base‑editing therapy nexiguran ziclumeran (nex‑z) for transthyretin amyloidosis with...