News
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.
FEATURED STORIES
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
THE LATEST
Vir Biotechnology reported Wednesday that its monoclonal antibody tobevibart, as a monotherapy and in combination with Alynylam-partnered elebsiran, achieved high rates of virologic response at week 24 in patients with chronic hepatitis delta.
More than 50% of nonalcoholic steatohepatitis patients treated with Eli Lilly’s tirzepatide saw at least a one-stage improvement in fibrosis, according to the pharma’s latest mid-stage readout.
The U.K.’s National Institute for Health and Care Excellence has endorsed the use of Eli Lilly’s Zepboundfor weight management in patients with BMI of 35 kg/m2 and above and at least one weight-related comorbidity.
Viking Therapeutics’ nonalcoholic steatohepatitis candidate VK2809 significantly improved secondary histologic endpoints at 52 weeks with no worsening of fibrosis, as assessed by hepatic biopsy.
An FDA advisory committee on Tuesday overwhelmingly rejected Lykos Therapeutics’ investigational MDMA-assisted therapy for post-traumatic stress disorder due to safety concerns and how the company conducted its trials.
In this deep dive BioSpace analyzes the neuropsychedelic therapeutics pipeline, which grabbed headlines in February when the FDA accepted the New Drug Application for Lykos Therapeutics’ MDMA capsules for PTSD.
Annexon’s late-stage Guillain-Barré syndrome trial has hit its primary endpoint and laid the foundation for a filing for approval next year, the company said Tuesday.
Illumina on Monday announced that its board of directors is spinning off Grail and has applied to list the cancer diagnostics company on the Nasdaq.
BridgeBio’s oral small molecule infigratinib is proceeding with a late-stage study in children with achondroplasia after it improved body proportionality and height in children with dwarfism, the company announced Tuesday.
Analysts predict a booming year for mergers and acquisitions, powered by obesity drug sales and pressure from upcoming patent expirations.