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Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.
FEATURED STORIES
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Read our takes on the biggest stories happening in the industry.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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The partnership splits the rights to Stoke’s epilepsy antisense oligonucleotide, with up to $385 million in potential payments due to Stoke.
Back in 2023, Novo Nordisk committed up to $1.3 billion for a hypertension and kidney disease drug from KBP Biosciences. Now, the pharma giant claims to have been misled by the biotech’s founder—and a judge seems to agree.
AlgoTherapeutix blames a “strong placebo effect” for the mid-stage failure for its pain gel ATX01, but the company still believes in the promise of its candidate as Vertex Pharmaceuticals’ first-in-class drug Journavx opens up the non-opioid space.
In the first podcast in a special series focused on BioSpace’s NextGen Class of 2025, Senior Editor Annalee Armstrong speaks with Dannielle Appelhans, CEO of COUR.
Casdatifan’s progression-free survival benefits could help differentiate it from Merck’s Welireg in the kidney cancer arena, according to analysts at Truist Securities.
COUR Pharmaceuticals has been around a while, but not until last year did the company solidify behind its ultimate mission with a series A raise.
The hammer came down on an unspecified number of FDA employees this weekend, days after Robert F. Kennedy Jr. was confirmed as HHS Secretary.
The approvals come as Robert F. Kennedy Jr.—who has been critical of vaccines—takes leadership of the Department of Health and Human Services.
Ono picked up Romvimza—previously known by its active ingredient vimseltinib—from its $2.4 billion acquisition of Deciphera Pharmaceuticals in April 2024.
Merilog’s approval comes as the insulin space has over the past year suffered several setbacks, including strong calls for price caps and, potentially, the rise of the mammoth GLP-1 market.