News
Encouraging data for combination regimens of Revolution Medicines’ zoldonrasib “reinforce the path to leadership in PDAC” for the biotech, according to Truist Securities.
FEATURED STORIES
The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
Gilead, AstraZeneca and Vertex have acquired more than just a therapeutic asset in recent deals. BioSpace takes a look at five recent transactions where the staff was the real centerpiece.
BioSpace looks back at 2025 and where the FDA is going in 2026.
The draft guidance supports the agency’s new pathway designed to speed up the development of custom gene therapies.
By closing the Universal Cells Seattle location, Astellas is reportedly consolidating cell therapy, gene therapy and oncology research at its South San Francisco, California, and Westborough, Massachusetts, sites.
In this bonus episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel take a look at Q1 job market performance and what it signals for the coming months.
With robust sales performance from oncology darling Darzalex and immunology superstar Tremfya, Johnson & Johnson is “off to a fast start in 2026,” CEO Joaquin Duato told investors on Tuesday.
With many overseas patients preferring orals to injectables, Eli Lilly has filed for approval of orforglipron in more than 40 countries and is building manufacturing capacity to support the obesity drug.
Eli Lilly is putting its obesity windfall to work again, striking a new deal to acquire CrossBridge Bio, a small Texas biotech known for its cancer tech.
During the pharma earnings season, which begins on Tuesday, Novo Nordisk will report the first revenue numbers from an oral GLP-1 medicine, while other companies are expected to address the FDA, drug pricing and Trump’s new tariffs.
The FDA has greenlit Travere Therapeutics’ Filspari as the only available treatment for focal segmental glomerulosclerosis despite the drug’s loss to Sanofi’s Avapro in a Phase 3 study.