Ex-FDA Neuroscience Director Billy Dunn was appointed to Prothena’s board of directors last week. Industry representatives and regulatory experts weigh in on the potential ethical implications.
Tag Archive for: FDA
Shares of Intercept Pharmaceuticals fell 16% on Monday over concerns about the prospects of the company’s drug to treat a type of fatty liver disease after the regulator’s advisory panel voted to defer an accelerated approval.
With Friday’s approval, Epkinly edges out Roche’s bi-specific antibody glofitamab, which is also being proposed for diffuse large B-cell lymphoma.
The regulator’s approval makes Miebo the first DED treatment that directly addresses tear evaporation. The drug is expected to hit U.S. markets in the second half of 2023.
The FDA has cleared Thermo Fisher Scientific’s test, the first of its kind in the country, to detect women with risk of severe preeclampsia, the company said.
The FDA’s advisory committee voted unanimously that available data supported the vaccine’s efficacy for giving the shot to women in their second or third trimesters of pregnancy to prevent lower respiratory tract infection and severe disease in infants up to 6 months of age.
Abrysvo, Pfizer’s investigational vaccine for respiratory syncytial virus infection, appears to be safe and effective in the pediatric setting, according to the FDA’s briefing document published ahead of an advisory committee meeting.
While media attention has focused on the availability of abortions, take note: contradictory court decisions about mifepristone broadly threaten the authority of the Food and Drug Administration (FDA) to approve and regulate new medications for any indication.
The agency’s briefing documents highlighted increased risk of diabetes and liver injury from using the obeticholic acid oral tablets for treatment of nonalcoholic steatohepatitis.
The justices turned away Israel-based Teva’s appeal of a lower court’s ruling reinstating the jury award for U.K.-based GSK. The case involves “skinny labels,” which allow generic drugmakers to avoid patent lawsuits if a generic drug’s label omits potentially infringing uses of a brand-name drug.
