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During its Q1 earnings call Tuesday, Biogen announced a handful of program pauses and cuts and touted the potential of anticipated approvals.
Orbital will use Series A funds to advance RNA-based vaccines, immunomodulators and protein replacement therapies.
The proposed drug pricing legislations follow the Inflation Reduction Act, passed in August 2022.
Novartis is scaling back its pipeline to focus on higher-value assets with stronger commercial potential.
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.
Tuesday, the FDA approved Qalsody—formerly tofersen—on a conditional basis to treat SOD1-ALS.
For those looking to transition out of academia, moving into a government role could be one of the most rewarding pathways available.
Govorestat failed its primary composite measure but showed signals of efficacy, leading the company to push forward with an NDA.
The partial clinical hold follows Foghorn’s voluntary pause of the study and is due to one patient developing irregular heartbeat following treatment with FHD-609.
Eplontersen halted ATTRv-PN disease progression and improved quality of life through 66 weeks. The drug has a PDUFA date of Dec. 22, 2023.
To give the FDA more time to evaluate updates to quizartinib’s proposed REMS program, the regulator is pushing the target action date to July 24.
Friday, the Supreme Court granted the FDA’s application for a stay, effectively maintaining access to the abortion pill mifepristone as its case goes through the appeals process.
The FDA’s Center for Biologics Evaluation and Research is aiming to recreate the success achieved with the rapid development of COVID-19 vaccines under a program of the same name.
This week, the FDA will release its verdict on Biogen and Ionis’ ALS candidate tofersen and three other investigational medicines for psychiatric disorders, hormonal insufficiency and gut infection.
Cancer vaccines enjoyed a moment in the spotlight this week as Moderna, Merck, Nykode Therapeutics and Transgene shared promising updates at AACR and beyond.
AbbVie shared more positive results for its migraine prevention drug, Qulipta, just three days after FDA approval to expand its label.
The deal could be worth more than $1 billion, starting with an upfront payment of $22.75 million.
Moderna claims it can have vaccines ready for multiple cancer types by 2030, but experts say challenges remain.
The checkpoint inhibitor is approved for several cancers in China, but after an indefinite FDA delay last summer, BeiGene’s partner Novartis still awaits its first U.S. approval.