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.
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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
Following clearer overall survival data from the PSMAfore trial, Novartis on Thursday affirmed plans to file for a prostate cancer label expansion for its targeted radioligand therapy Pluvicto later this year.
Due to slow uptake of its Humira biosimilar Cyltezo in the U.S., Boehringer Ingelheim is laying off an undisclosed number of its sales employees, Reuters reported on Thursday.
Basilea Pharmaceutica received FDA approval for its antibiotic Zevtera in three indications Wednesday, finally getting the drug across the finish line a decade and a half after the agency rejected an earlier submission.
Amid a flurry of deals in the antibody-drug conjugate space, Merck KGaA is getting in on the action with a partnership with Caris Life Sciences to accelerate the discovery and development of first-in-class ADCs for oncology.
Following disappointing late-stage data, Amylyx on Thursday said it is withdrawing the company’s amyotrophic lateral sclerosis drug Relyvrio from the U.S. and Canadian markets and cutting its workforce by approximately 70%.
Three Biopharma firms disclosed concerns about how emerging geopolitical tensions between the U.S. and China might impact their business with the contract manufacturer.
A Delaware judge on Wednesday agreed with Roivant subsidiary Arbutus and Genevant’s interpretation of specific patent claims regarding the lipid nanoparticle delivery system used by Moderna’s COVID-19 vaccine.
Sanofi has in principle reached a settlement related to its discontinued heartburn drug Zantac, though the French pharma did not disclose the financial terms of the deal.
Congress and the Biden administration have set their sights on lowering prescription drug costs.
Fierce competition. Thin pipelines. Patent cliffs. The stakes are sky-high for pharmaceutical companies and investors alike.