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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy families have turned to the news for answers. Meanwhile, the FDA insists it remains committed to notifying companies of any regulatory action before sharing information with the media or public.
Delays in the decision dates for high-dose Eylea are linked to issues at a Catalent-owned facility. Once these are resolved, Regeneron expects “to receive favorable action” on these applications, CEO Leonard Schleifer told investors.
A U.K. Court of Appeals ruling confirms the validity of a patent covering modifications of mRNA used in Moderna’s vaccines.
It’s not often that a CEO outright dismisses M&A prospects, but Moderna CEO Stéphane Bancel says the mRNA biotech has enough programs on its hands.
The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research into one entity.
In its first commercial quarter for ATTR-cardiomyopathy, Alnylam’s Amvuttra reached roughly 1,400 patients and made more than $490 million.
Merck has characterized its cost-cutting initiative as more of a reallocation of resources to support other, higher-growth areas of its business.
In 17 identical letters posted to his Truth Social account, the president said companies must lower their prices or the government ‘will deploy every tool in our arsenal to protect American families from continued drug pricing practices.’
The FDA greenlit multiple new drugs this month and issued some notable label expansions, including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome.
Bristol Myers Squibb tested Cobenfy as an adjunctive treatment with atypical antipsychotics for schizophrenia in the Phase III ARISE study, which earlier this year failed to demonstrate significant symptom improvement.
For now, Sanofi’s U.S. inventory is insulating the company from a potential 15% tariff on drugs shipped from the EU.
Move over Humira, Skyrizi and Rinvoq are expected to beat the former megablockbuster’s peak sales by the end of this year.
PRESS RELEASES
• ASCO 2026: 2.5-Year Overall Survival Data • Jefferies Healthcare Conference: Partnering & Investor meetings • BIO International Convention: Panel Participation • MIB Agents Factor Osteosarcoma Conference: Data Presentation
The 6% naturally derived extract is set to be encapsulated for use in patients suffering from treatment-resistant depression under Australia’s Authorised Prescriber Scheme, where no serious adverse events have been reported as of December 2025
Live Presentation and Q&A: Thursday, May 28, 2026 12 PM EDT
• MustGrow has received approval from the agriculture departments of Texas, Utah, and Montana to commence sales of organic biofertility product TerraSanteTM. • Based on infield grower data, the mustard-derived TerraSanteTM biofertility product has been shown to improve crop yields, soil, and potentially the soil microbiome health for nutrient/water use efficiencies.
· Prof. Dr. med. Jürgen Braun joins the Scientific Advisory Board of MetrioPharm AG. · With more than 800 peer-reviewed publications and various prestigious awards, Prof. Braun is internationally recognized as a leading expert in the field of modern clinical and academic rheumatology.
Pharmaceutical service provider receives prestigious management award for the seventh year in a row · Family-owned company once again excels in all four key business areas · Site development and digitalization as strategic investment priorities · Focus on new sources for skilled workers and on lifelong learning
The upgraded platform offers a searchable database of over 300 risk-assessed HCPs, automated research scanning, and new flexible pricing options for mid-size drug developers.
New preprint by Jianghui Xiong, PhD, and the DeepoMe team introduces SteeraMed, a steerable biomedical world model for N-of-1 intervention reasoning across chronic diseases and aging