Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Daiichi Sankyo is taking Seattle Genetics to court over the technology the two companies used to develop antibody-drug conjugates during a partnership that spanned seven years.
A*STAR’s Institute of Bioengineering and Nanotechnology has teamed up with the Singapore Institute of Advanced Medicine Holdings Pte Ltd to explore how to better tackle nasopharyngeal carcinoma, a type of head and neck cancer, through targeted proton therapy.
Shanghai Green Valley Pharmaceuticals announced that China’s National Medical Products Administration has approved Oligomannate as new drug for the treatment of mild to moderate Alzheimer’s disease.
Researchers with the National Institute on Aging published research of a gene variant, APO3 Christchurch (APOE3ch), that appears to confer resistance to Alzheimer’s disease.
Endorsement of pivotal development program in recurrent glioblastoma (rGBM) from both EMA and FDA
AVEO said it received preliminary feedback from the FDA and the regulatory agency recommended not filing the NDA at this time based on its assessment of the totality of evidence in the Phase III trial.
Late Friday, President Donald Trump put forth Hahn’s name to take over the top spot of the nation’s regulatory agency.
An international team of researchers have put forward a position statement, published in Science, whichlays out a new healthcare framework to help aging populations stay healthier for longer.
Reston Hospital Center has recently renewed accreditation as a Center of Excellence in Minimally Invasive Gynecology by Surgical Review Corporation This accreditation distinguishes Reston Hospital Center from many other surgical facilities by providing the highest quality of care to patients as determined by an independent, external process of evaluation.
Centrient Pharmaceuticals, the global leader in the production and commercialisation of sustainable antibiotics, next generation statins and anti-fungals, is proud to announce it has received a Gold Sustainability rating from EcoVadis.