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FDA
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 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.
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Follow along as BioSpace tracks job cuts and restructuring initiatives.
FROM OUR EDITORS
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.
THE LATEST
Co-founded by Nobel Prize winner Carolyn Bertozzi, Firefly’s venture funding is backed by Eli Lilly and Versant Ventures, among others, to support its novel platform for merging antibody-drug conjugates with protein degraders.
Freenome announced Thursday a fundraising round of more than a quarter of a billion dollars, led by Roche, to advance its blood-based cancer tests as pivotal readouts approach.
A longer-acting formulation of Otsuka Pharmaceuticals’ aripiprazole could help soften the blow of Abilify Maintena’s loss of exclusivity coming later this year, according to a new report from GlobalData.
Despite missing out on an FDA approval for major depressive disorder, Zurzuvae appears to be a strong asset for Sage Therapeutics, with high growth potential in 2024.
FDA
Eicos Sciences’ injectable vasodilator Aurlumyn is the first FDA-approved medication for severe frostbite to reduce the risk of finger or toe amputation by opening blood vessels and preventing clotting.
If you’re a researcher looking for your next challenge, check out these companies with current openings on BioSpace.
Changes to U.S. visa policy in 2022 reportedly increased the number of foreign-born STEM workers, but some say more needs to be done to ensure companies can hire the best talent.
The Federal Trade Commission and Department of Health and Human Services on Wednesday said they are investigating group purchasing organizations and drug wholesalers’ possible involvement.
This week, Greg, Heather and Tyler discuss reaction to ⁠Novo Nordisk’s purchase of Catalent⁠ and speculate on what that means for existing manufacturing contracts, customers and consequences with ⁠regulators⁠.
The Department of Justice is seeking more information regarding Biogen’s overseas operations, while the Securities and Exchange Commission is looking into the launch of the now-defunct Alzheimer’s disease therapy Aduhelm.