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Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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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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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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Analysts at Guggenheim Partners expect Voyxact to see “broad commercial uptake” given its relatively broad label compared with previous accelerated approvals for IgA nephropathy.
The discounts should be compared against the drugs’ “ultimate net price” rather than their indicated list price to gauge the true impact of the negotiations, BMO Capital Markets analysts said.
Imfinzi is the first immunotherapy approved for perioperative use to treat gastric and gastroesophageal junction cancers.
A coordinated national effort is emerging to bring alternatives to animal testing into routine preclinical use, backed by a fresh FDA roadmap and a global coalition of scientific and industry partners.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access to patients two years and older in what one Stanford Medicine professor called a “game changing advance” for the field.
At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts at BMO Capital Markets.
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or refractory multiple myeloma, results analysts at Guggenheim Securities called “remarkable.”