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Once fully operational, the Pennsylvania site will employ more than 500 people and make cell therapies for thousands of patients a year.
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Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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Read our takes on the biggest stories happening in the industry.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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Establishing trust through thought leadership is no longer optional in today’s cautious biopharma market. Learn how strategic insights and targeted outreach can turn awareness into high-converting leads.
Phase Ib data show Hernexeos can elicit a confirmed objective response rate of 44% in patients with HER2-mutated NSCLC who had previously been treated with a directed antibody-drug conjugate.
Gray Delany’s ouster comes days after Health Secretary Robert F. Kennedy Jr. controversially axed 22 mRNA vaccine contracts under the Biomedical Advanced Research and Development Authority.
Skysona can now only be used in patients with cerebral adrenoleukodystrophy who have no available treatment alternatives or stem cell donors.
The Future of Cell and Gene Therapy: Navigating Innovation, Regulation, and Manufacturing Challenges
An interview with Philip Vanek, chief commercialization officer of the International Society for Cell & Gene Therapy (ISCT), reveals both promising developments and significant concerns shaping the advanced therapies sector’s trajectory through 2025 and beyond. This interview was conducted with support from Tozaro.
In the wake of multiple patient deaths from liver injuries related to Sarepta Therapeutics’ AAV gene therapy platform, some in the sector are looking for ways to improve the current technology, while others are eager to move on.
The recent announcement of RFK Jr.’s termination of mRNA vaccine contracts is the latest effort to undermine this promising technology at the federal level. Pharmaceutical companies and private investors must fill the gap and ensure that research into this critical resource continues.
Here are five oral obesity candidates that, according to Mizuho’s Graig Suvannavejh, could change the weight loss game.
Arguably the FDA’s most anticipated decision this month is for a subcutaneous induction formulation of Biogen and Eisai’s Alzheimer’s drug Leqembi, which, according to Eisai, could “help reduce the burden on healthcare professionals and patients.”
After exiting the FDA less than two weeks ago for unclear reasons, Vinay Prasad is once again director of the Center for Biologics Evaluation and Research, HHS confirmed to several outlets Saturday.