The Food and Drug Administration warning letter detailed unreported low blood sugar and a software change to correct for delayed glucose readings.
FDA warns Beta Bionics on unreported complaints, insulin pump changes Read More »
Boston Scientific’s planned $14.5 billion acquisition of Penumbra is the largest deal of the year so far.
Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.
FDA’s One Trial Policy Not a Revolution but a Potentially Risky Evolution Read More »
After a rocky 2025, Sarepta Therapeutics’ executives admit they have work to do to bring patients back into the fold as sales of Duchenne muscular dystrophy gene therapy Elevidys continue to decline.
After Sarepta’s Annus Horribilis, Elevidys Sales Expected To Continue Downward Spiral Read More »
While Boehringer Ingelheim hasn’t yet revealed what diseases it will go after, Sitryx’s oral drug candidate could potentially be disease-modifying for a variety of autoimmune and inflammatory conditions.
Boehringer Seeks To Rebalance Immunity With Sitryx Collab Potentially Worth $500M+ Read More »
In this episode of Denatured, you’ll be listening to Indu Navar, CEO and founder of EverythingALS and Dr. Olga Uspenskaya, chief medical officer at VectorY Therapeutics. We’ll be speaking about patient-pharma collaborations accelerating trials and hope, advances in ALS biology understanding and biomarker-driven endpoints.
ALS Advances Unite Patients and Pharma on Novel Targets, Biomarker Breakthroughs Read More »
At the 2026 Conference on Retroviruses and Opportunistic Infections, Gilead and Merck demonstrated that their respective daily oral HIV drugs can match current therapies in keeping the virus at bay.
Gilead, Merck Clear Path to Market for Daily HIV Pills With New Late-Stage Data Read More »
The rejection of Atara Biotherapeutics’ Ebvallo in January was a “complete reversal” of the conesensus FDA reviewers had come to, according to a former agency employee, who said manufacturing problems were the only approvability barrier for the drug.
Atara Climbs Amid Report of FDA Inconsistency Leading to Cell Therapy’s Rejection Read More »
Novo Nordisk reported a loss in a head-to-head trial of CagriSema against Lilly’s Zepbound earlier this week. This time around, Lilly’s orforglipron bested Novo’s oral Wegovy in blood sugar control and weight reduction—albeit with a few extra discontinuations as compared to its rival.
Lilly Tops Novo in Weight Loss Again, This Time on the Oral Front Read More »
En dos estudios recientes se ha averiguado cómo las moléculas orgánicas complejas, precursores químicos esenciales de la vida, pudieron incorporarse en las cuatro lunas principales de Júpiter durante sus respectivos procesos de formación. Estos satéli …
Nuevos hallazgos sobre el potencial químico para la vida en las lunas de Júpiter Read More »
