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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
The FDA’s priority review acceptance of BridgeBio’s BBP-418 is another step toward what William Blair previously dubbed a “diversified commercial portfolio.” It also adds to the rapidly building momentum in muscular dystrophy more broadly.
Apogee’s pipeline in a product drug zumilokibart achieved significant disease clearance in a mid-stage atopic dermatitis trial, but investors were miffed by a royalty financing deal with Blackstone.
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.
Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
The FDA will convene its vaccines advisory panel to discuss seasonal COVID-19 vaccines—a surprise move after Health Secretary and vaccine skeptic Robert F. Kennedy, Jr. overhauled a separate vaccine committee.
An FDA advisory committee recently voted against approving AstraZeneca’s oral SERD drug camizestrant for certain patients with advanced breast cancer. It is unclear when the new target action date for the drug will be.
Nearly 80% of patients saw tumor shrinkage after being treated with Kura Oncology’s darlifarnib plus Bristol Myers Squibb’s Krazati, findings Mizuho analysts say could open up a $2 billion opportunity for the biotech.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
Eli Lilly continues to spend its GLP-1 landfall with four new deals in the past week, including three in the vaccine space; the obesity leader also touted surgery-like results for its next-gen weight loss drug; Moderna’s stock climbs on the hantavirus “fear trade”; and in oncology, all eyes are on Revolution at ASCO this week.
The people most trusted to deliver are not always the ones invited to shape direction. Executive coach Angela Justice examines why the habits that build a career can eventually limit advancement.
Strong science and early support are not enough on their own. Europe needs more capital depth, cross-border investor backing and a lighter policy framework to keep companies scaling at home, according to two venture capitalists.
PRESS RELEASES
- Inobrodib in combination with pomalidomide + dexamethasone (InoPd) demonstrates strong clinical efficacy and a tolerable safety profile in heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients - - Observed response rates of 60-75% with inobrodib 20 mg and 30 mg cohorts result in clinical efficacy at least two-fold higher than previously published real-world data for pom-refractory, bispecific or anti-BCMA exposed patients -
Intricon completes construction of its Evolution Free Zone location, combines with Minnetronix Medical, and will fly the Forj Medical flag at its new site; equipment and workforce move into place for the grand opening
Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study design Biomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with pending analysis awaiting alignment with US FDA on biomarker statistical analysis plan to be discussed at upcoming December 11, 2025 FDA Type C Meeting Company reiterates end of January 2026 timeline for MAA submission