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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.

Follow along as BioSpace tracks job cuts and restructuring initiatives.

Replimune’s resubmission for RP1 for melanoma comes after the departures of FDA leaders in place at the time of the drug’s first two rejections. The FDA expects to hold an advisory committee meeting in late July.

Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.

When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.

The positive ADHD data for Otsuka Pharmaceutical’s centanafadine is good news in what has of late been a mixed bag for the neuropsychiatric space.

Jefferies expects Moderna to have around seven commercial products in the coming years which, along with a projected 10% revenue growth, could help the company break even in 2028.

The company is “especially excited” about an immune cell therapy manufacturing technology included in the deal, a Merck KGaA executive said.

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.

In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll hear from Hakan Goker, managing director at M Ventures and Maina Bhaman, partner at Sofinnova Partners. We explore the UK biotech ecosystem: from the Golden Triangle’s evolving role to the challenges of scaling companies, unlocking pension capital and staying globally competitive.

Encouraging data for combination regimens of Revolution Medicines’ zoldonrasib “reinforce the path to leadership in PDAC” for the biotech, according to Truist Securities.

• Company expects approximately $2 million in non-dilutive VAT refunds from wholly owned U.K. subsidiary in 2Q-26 • Company expects to receive approximately $2 million in non-dilutive R&D tax credits repayable to the company in cash from its U.K. subsidiary in 2H-26 • Offering net proceeds, together with funds expected to be received via U.K. subsidiary, expected to provide cash runway into 2027 • Company expects to receive approvals in the U.S., U.K. and Europe for OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma in the second half of 2026

34-acre campus supports 200,000 square feet of GMP manufacturing, with long-term expansion capacity exceeding one million square feet