News
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
FEATURED STORIES
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
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
Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
By partnering with a UN-backed body, Roche has enabled companies to make the medicine for supply in 129 countries.
Lilly met analysts’ sky-high expectations with 28.3% weight loss over 80 weeks for the triple hormone receptor agonist retatrutide in a highly anticipated readout on Thursday.
In September last year, a group of concerned stockholders raised alarm about Vaxart’s proposed reverse stock split, which the biotech was pushing for despite strong opposition from shareholders.
A trifecta of newly inked tech partnerships—from Eli Lilly, Bristol Myers Squibb and Incyte—exemplify the increasingly central role that AI is playing in drug development.
After being hit by safety issues and subpar results in another trial, BioMarin’s Phase 3 test of Voxzogo for a rare skeletal disorder called hypochondroplasia showed efficacy “solidly above” what the drug has shown for achondroplasia, which causes dwarfism.
In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll be hearing from Regina Hodits, managing director at Angelini Ventures and Sofia Ioannidou, VC partner at Andera Life Sciences. They explore Germany’s biotech and life sciences ecosystem, including the science, infrastructure and policy changes needed to help European companies scale globally while staying rooted in Europe.
The number of biotech and pharma professionals taking jobs they’re overqualified for is now over 50%, based on a BioSpace LinkedIn poll. A recruiting firm executive discusses the trend, the reasons behind it and why it doesn’t have to derail careers.
Eli Lilly joins hands with Engage Bio, acquiring the DNA delivery platform developer in hopes of bolstering its genetic medicines portfolio.
While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”