News
City Therapeutics, one of BioSpace’s NextGen companies for 2026, was started by RNA royalty John Maraganore, former CEO of Alnylam.
FEATURED STORIES
After a $625 million IPO, the biggest ever in biotech, obesity-focused Kailera Therapeutics is readying a commercial strategy that puts patients at the center.
The FDA has expanded the regulatory toolkit during President Donald Trump’s second term, adding new mechanisms for rare diseases while putting the Biden-era platform technology designation into action.
As the FDA tries to clarify its intent for former FDA Commissioner Marty Makary’s plausible mechanism framework for bespoke therapies, experts emphasize the importance of expanding its scope to encompass rare diseases that affect more than just one or a few individuals.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
THE LATEST
The Belgian drugmaker plans to hire about 330 people at a facility that will use advanced manufacturing technologies including AI, robotics and automation to meet rising demand for key products. This will be UCB’s first biologics manufacturing facility in the U.S.
Looking for a biopharma job in New York? Check out the BioSpace list of 11 companies hiring life sciences professionals like you.
Merck’s acquisition of Terns Pharmaceuticals follows other big-ticket purchases, including of Verona Pharma and Cidara Therapeutics, as the pharma prepares for the impending expiration of its blockbuster’s patents.
Missing one of its co-primary endpoints could make it difficult for Karyopharm Therapeutics to score conventional approval for Xpovio in myelofibrosis, according to Jefferies analysts.
While RA Capital Management has yet to commit to a merger plan, it noted that its new blank-check company, Research Alliance III, could target companies abroad, including those from China.
Gilead continues its dealmaking spree in the sizzling hot space of I&I as Johnson & Johnson, along with partner Protagonist, notched an FDA approval for a new psoriasis drug. Plus, Aurinia Pharmaceuticals gets a new C-suite, FDA releases draft guidance on non-animal models and the CDC’s vaccine advisory committee is not being disbanded after all.
Overall, the top 16 largest pharmaceutical companies spent $159 billion on research and development in 2025, compared to $165 billion the year prior. Here’s where all that cash went at companies like Johnson & Johnson, Amgen and Pfizer.
Trace Neuroscience, a member of BioSpace’s NextGen Class of 2026, has learned from the success of Biogen’s Qalsody and aims to bring more treatment options to the ALS community.
While ersodetug missed the Phase 3 primary endpoint of a reduction in hypoglycemia events, Rezolute argued that this goal was confounded in part by behavioral factors. The FDA acknowledged the validity of this argument.
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.