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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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Former Agilent Technologies executive Jacob Thaysen will take the reins later this month replacing CEO Francis deSouza, who stepped down in June following a proxy fight with activist investor Carl Icahn.
The company Tuesday posted Sandoz’s financial performance for the first half of 2023, as it looks to secure the approval of shareholders this month for the generics and biosimilars spin-off.
The Swiss pharmaceutical company filed a suit Friday joining a growing group of legal complaints by Big Pharma seeking to block the Inflation Reduction Act’s Drug Price Negotiation Program.
The companies are moving closer to traditional approval for the antibody-drug conjugate Tivdak, which met its primary endpoint for overall survival in an interim analysis.
$27.8B Amgen-Horizon deal gets FTC clearance with restrictions; the White House names first 10 drugs subject to Medicare price negotiations; Sage Therapeutics axes 40% of staff.
The vaccine was effective against previous COVID-19 variants but lacked efficacy against new ones, the company announced Thursday, leaving the booster no commercially viable options.
Under a consent order agreement announced Friday, Amgen is prohibited from bundling any of its products with Horizon’s Tepezza or Krystexxa, allaying the FTC’s primary concerns.
The antibody-drug conjugate will be pitted against chemotherapy in a heavily treated breast cancer subpopulation, with hopes of challenging AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu.
Two Democratic senators on Thursday sent a letter to the companies’ CEOs informing them that they have until Sept. 15 to disclose the application processes for their insulin assistance programs.
After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.