Drug Development
After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.
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Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
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The FDA clinical hold comes after Alpine reported a patient died during the NEON-2 trial.
OptiNose AS announced that its Phase III ReOpen1 clinical trial met both of its co-primary endpoints. It will be used to treat patients diagnosed with chronic sinusitis.
As state and local governments across the United States begin to lift mitigation efforts, the death toll continues to climb across the globe, a reminder that COVID-19 is still a serious public health concern.
The Phase I study could potentially result in RP-A501 becoming the first gene therapy for monogenic heart failure.
The biopharma industry ended February and began March with plenty of clinical trial news. BioSpace shares the highlights.
Although at-home testing for COVID-19 has been dismal, the revolution in at-home testing has inspired personal tests for several other illnesses.
As COVID-19 cases fall in the wake of the latest surge from the Omicron variant, the question on the minds of many is, what comes next for these Pfizer and Moderna?
The FDA turned down Ocugen’s Emergency Use Authorization request for Covaxin in children 2 to 18, which the company is co-developing with India’s Bharat Biotech.
A study in monkeys found the virus infects the male genital tissues. For that and more COVID-19 news, continue reading.
Six months into the job, Chief Executive Officer Deepa Prasad left vTv Therapeutics. Not long ago, the former CEO dramatically slashed its workforce to ensure funding for its lead diabetes asset.