News
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.
FEATURED STORIES
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.
FROM OUR EDITORS
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.
THE LATEST
Following the regulator’s request for more data beyond the scope of its Phase III TIDES trial, Takeda decided to voluntarily withdraw the Biologics License Application for its TAK-003 dengue vaccine.
The company’s ruxolitinib cream Opzelura led to higher rates of treatment success in children with atopic dermatitis than with a control cream.
Severe respiratory problems killed seven patients and affected five others, though the company said that most of these were likely unrelated to the drug.
After paying $300 million upfront to BeiGene for option rights to ociperlimab in December 2021, Novartis has dropped the agreement and given the rights back to the Chinese biotech.
A handful of biotechs and pharma companies have posted sizable IPOs in 2023, despite a tight economy. Still, the numbers are way down from last year.
Burjeel Holdings and BridgeBio Pharma ink partnership deal in rare genetic diseases with a plan to set up headquarters in Abu Dhabi.
Bristol Myers Squibb is paying a total of $95 million to the two companies for exclusive global rights to programs developed within long-term partnerships designed to further BMS’ neuro pipeline.
Following its $5.9 billion Iveric Bio buy, Astellas is leaning into the eye disease space with a licensing agreement for 4D Molecular Therapeutics’ proprietary intravitreal AAV delivery system.
Despite a government report showing that hiring slowed over the month of June, job postings on BioSpace’s life sciences-focused job board saw a marked increase.
Early-stage data shows that Viridian’s thyroid eye disease candidate induces clinically meaningful improvements in eye protrusion after six weeks of treatment.