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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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The company has several targeted therapeutics in early-stage trials and preclinical development for cancer types with high expression levels of the protein.
The lawsuit, brought by Arbutus Biopharma, marks the latest legal action in an ongoing battle for intellectual property underlying mRNA vaccines for COVID-19.
Liver toxicities triggered a partial clinical hold on Merck KGaA’s trial studying its BTK inhibitor candidate for multiple sclerosis.
Junshi Biosciences announced Tuesday that its ovarian cancer candidate, senaparib, met the primary endpoint in a Phase III interim analysis.
Following mixed Phase I/II data for its homocystinuria hopeful pegtarviliase, Aeglea lays off all but 10 employees and launches a sweeping strategic review.
An interim analysis of the Phase III P302 study showed Moderna’s investigational flu shot, mRNA-1010, fell short of the statistical threshold for early success.
A California judge denied Elizabeth Holmes’ motion for release pending appeal, ruling that the former Theranos CEO must serve her prison sentence while she appeals her guilty verdict.
Data from two mid-stage studies show HI-Bio’s investigational therapy felzartamab lowers pathogenic antibody titers in patients with primary membranous nephropathy (PMN).
Karuna Therapeutics’ KarXT and Acadia Pharmaceuticals’ pimavanserin are sparking hope that a treatment for the negative symptoms of schizophrenia could be on the horizon.
In an open letter published Monday, more than 480 biopharma industry leaders expressed their support for the FDA after a Texas federal judge ruled to hold the approval of the abortion pill mifepristone.