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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Back in August, China’s Center for Drug Evaluation, its version of the U.S. Food and Drug Administration (FDA), fast-tracked 48 drugs that had already been approved in the U.S., Japan or Europe. These approvals reflect changes to China’s drug pharmaceutical environment.
The Centers for Medicare and Medicaid Services issues a number of proposals that could reduce the price of prescription drugs on Medicare plans.
The U.S. Food and Drug Administration (FDA) gave the green light late Monday to Bayer oncology drug Vitrakvi, a first-of-its-kind TRK inhibitor, after late-stage clinical trial results showed a 75 percent overall response rate and 22 percent complete response rate across various solid tumors.
Auris Medical Holding AG today announced the results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA), where the FDA addressed the Company’s questions and provided guidance on its AM-201 program with intranasal betahistine for the prevention of olanzapine-induced weight gain.
Promore Pharma AB, a Swedish biopharmaceutical developer of therapeutic peptides, today announced that the Drug Controller General in India (DCGI) has approved the company’s application to start a clinical Phase III study with PXL01 to prevent post-surgical adhesions after tendon repair surgery.
Event aimed at promoting a culture of innovation and to contribute in effort to achieve objectives of UAE national KPI on Cancer and cardio vascular diseases
Abu Dhabi based Maudsley Health, which is directly affiliated with the prestigious Maudsley Hospital in the UK, held their annual mental health conference under the patronage of H.E. Dr Yousif Al Serkal and the Ministry of Health and Prevention at the Al Amal Psychiatric Hospital, Dubai.
The campaign falls in line with the celebration of World Osteoporosis Day
As part of its strategy to provide the best electronic and smart services and enhance the quality of the healthcare system, the Ministry of Health and Prevention has launched an optional electronic service available on the website of the Ministry.
Both products are not registered for use in the UAE