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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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After oncology and neuroscience headlined biopharma investment in 2023, experts anticipate increased interest in the autoimmune and obesity spaces this year.
Varoglutamstat, a drug developed by German biotech Vivoryon Therapeutcs, did not hit its primary and secondary endpoints in a Phase IIb study in Alzheimer’s disease.
After stopping the study early due to strong efficacy, Novo Nordisk released data from the FLOW study showing significant benefits of semaglutide in patients with type 2 diabetes and chronic kidney disease.
The regulator has approved Eyenovia and Formosa’s ophthalmic clobetasol propionate solution to ease eye inflammation and pain after surgery, with a potential $1.3 billion market.
Hugel America has won the FDA’s approval for Letybo, authorized for the treatment of frown lines in adults, which is poised to challenge AbbVie’s blockbuster Botox.
Exosomes show potential to treat myriad conditions, including cancer and inflammation, but experts are divided on whether the therapies are ready for the limelight.
As BridgeBio’s acoramidis inches closer to an FDA approval decision, Bayer on Monday inked a European licensing agreement for the transthyretin amyloid cardiomyopathy treatment.
Pfizer’s oncology strategy to build up its biologics portfolio and dramatically reduce small molecules was influenced by the Inflation Reduction Act’s drug price negotiation provisions.
New 96-week data show Akero Therapeutics’ efruxifermin can improve fibrosis by at least one stage without metabolic dysfunction-associated steatohepatitis worsening in more patients versus placebo.
Amid the limitations of current therapies for amyotrophic lateral sclerosis, a new GlobalData report points to novel disease-modifying drug approaches that could transform the space.