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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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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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Phase III data showed that Inluriyo improves progression-free survival versus standard endocrine therapy.
Companies that have broken ground on or are actively constructing manufacturing facilities in the U.S. are exempted from the tariffs, according to President Donald Trump’s social media post on Thursday.
Though details remain scant, the pending order is expected to be the latest effort in President Donald Trump’s campaign to bring drug prices down to the same level as economically similar countries.
The regulatory greenlight was backed by two Phase III trials that showed normalized growth hormone levels in patients with the rare pituitary condition. It’s the first approval for Crinetics Pharmaceuticals and something CEO Scott Struthers predicted “will transform people’s lives.”
Looking for a biopharma job in Pennsylvania? Check out the BioSpace list of six companies hiring life sciences professionals like you.
The Trump administration’s recently announced fee for new H-1B visa petitions is “completely unreasonable,” an immigration attorney told BioSpace. Attorneys and talent acquisition experts discuss how the fee could impact biopharma and confusion around the proclamation.
Truist analysts called the results “encouraging” while pointing out certain unknowns in the data. Immuneering plans to kick off a registrational trial for atebimetinib later this year.
The decision to stop the Phase IIb study was driven by “strategic business reasons,” according to a federal clinical trials database.
Three draft recommendation documents published on Wednesday are intended to guide drug sponsors and accelerate the development of cell and gene therapies.
While Harmony management has not disclosed future plans for ZYN002, Jefferies analysts expect the asset to be shelved.