5 topics to watch as MDUFA negotiations restart
The next Medical Device User Fee Amendments, which will set how much the FDA can raise from the industry in fees over a five-year period, are expected to go to Congress this year.
The next Medical Device User Fee Amendments, which will set how much the FDA can raise from the industry in fees over a five-year period, are expected to go to Congress this year.
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
JPM26: With Leqembi Launched, Biogen Looks To Expand Alzheimer’s Presence Read More »
Cuando hace años un reconocido jugador se enfrentó por primera vez a una plataforma online, y siempre surgía la misma duda: ¿realmente entendemos qué es el azar cuando todo pasa en una pantalla y un servidor decide todo en segundos? Antes, en los casinos …
Biopharma companies—including AstraZeneca, BioNTech and Agios—peered farther into the future on the second day of JPM, setting both revenue and R&D targets through the end of the decade.
JPM26 Day 2: Companies Lay Out Near-Term Revenue, Longer-Term Business Goals Read More »
Conforme la NASA se acerca al lanzamiento espacial que marcará el inicio de la misión tripulada Artemis 2 a la Luna, la agencia se prepara para culminar las tareas de integración y diversas pruebas y ensayos relacionados con el futuro lanzamiento espacial. La primera mi …
Últimos preparativos para la primera misión tripulada a la Luna del programa Artemis Read More »
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
JPM26: Lilly Plots Path to Dominance as Obesity Market Enters a New Era Read More »
After a period of diversification, Novo Nordisk is returning to its roots by focusing on the 2 billion people with diabetes, obesity or overweight.
JPM26: Novo Refocuses on Diabetes and Obesity Amid Push To Expand GLP-1 Market Read More »
Epic alleges Health Gorilla and its clients retrieved nearly 300,000 patient records for financial gain. Health Gorilla argues the EHR vendor is attempting to stop the free flow of health data.
Epic, health systems sue Health Gorilla, others over improper access to medical records Read More »
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Trump Must Make Biotech Innovation a National Priority Read More »
El 11 de enero de 2026, un cohete Falcon 9 de SpaceX, portando el nuevo satélite astronómico Pandora de la NASA, despegó desde el complejo de lanzamiento 4E (SLC-4E) de la base de Vandenberg de la Fuerza Espacial estadounidense en California. El cohete llevó al e …