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Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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BioSpace looks at the challenges faced by the Latinx community in the life sciences, from the origins of the challenges, to educational gain and the importance of mentorship.
The FDA has decided to extend the Prescription Drug User Fee Act (PDUFA) review date for TG Therapeutics’s ublituximab until December 2022.
RhoVac AB announced Tuesday that its candidate therapeutic for prostate cancer failed to meet targets in a Phase IIb study.
GSK announced that it is acquiring Affinivax for up to $3.3 billion to gain its novel class of developmental vaccines and its MAPS technology.
The ASCO Annual Meeting being held in June 3 to 7 will introduce hundreds of posters, abstracts and presentations of cancer studies, preclinical and clinical. BioSpace looks at three presenters.
The long weekend saw BMS’s Opdivo, Novartis’s Kymriah and Roche’s Evrysdi win FDA approvals in new indications.
The initiative, a partnership between non-profit biotech company n-Lorem and Columbia University, focuses on developing personalized experimental ASO medicines for nano-rare ALS patients.
Although there are many mechanisms proposed that contribute to neuroinflammation and damage caused by inflammaging in the brain, INmune Bio has focused on tumor necrosis factor (TNF).
The American Society of Clinical Oncology meeting will be underway next week in Chicago, and companies are preparing to share data from their pipelines. Here’s a look.
Protagonist Therapeutics announced updated promising data from its phase II Revive clinical trial, which is evaluating the safety and efficacy of rusfertide in patients with polycythemia vera (PV).