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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The FDA said the approval of Teva’s product is the first generic naloxone nasal spray for use in a community setting by individuals without medical training.
Maryland-based United Therapeutics said Sandoz has had eight years to ensure it had its own delivery system in place for its generic pulmonary arterial hypertension medication.
The new initiative against opioids has a goal of reducing related deaths by as much as 40 percent.
FDA grants elafibranor Breakthrough Therapy Designation, based on Phase 2 data, for treatment of PBC (Primary Biliary Cholangitis) in adults with inadequate response to UDCA
Director Peter Marks said FY18 was productive and exciting as the FDA department continued to support the advancement of 21st century medicine.
COPD is a progressive disease associated with tobacco smoking, air pollution or occupational exposure. It results in difficulties in breathing and increasing episodes of breathlessness.
As Ned Sharpless takes over as acting commissioner of the U.S. Food and Drug Administration, he is not planning any disruptions or course corrections to the federal regulatory agency.
Poietis, 4D Bioprinting company, announces the issuance by the European Patent Office of a third patent covering its bioprinting technology
Company on Track to Submit NDA to FDA in Mid-2019
Karolinska Development’s portfolio company Aprea Therapeutics has from FDA received an Orphan Drug Designation for APR-246 for the treatment of patients with Myelodysplastic Syndromes having a TP53 mutation.