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Of the 13 programs that the companies will advance, four will come from Hengrui Pharma and four from Bristol Myers Squibb. The remaining five assets will be jointly discovered.
FEATURED STORIES
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
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.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
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The regulator found no issues with mirikizumab’s clinical or safety data.
New therapeutics for Major Depressive Disorder could change the treatment landscape and give patients more options.
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).