The FDA’s decision to decline the drug’s approval for a much larger cohort of patients with clinical depression, along with strict safety warnings for its use in PPD, is still a “strike against (Biogen’s) management”, Baird analyst Brian Skorney said.
Tag Archive for: pregnancy
Having access to an oral medication will be a beneficial option for many of women coping with PPD and having extreme, and sometimes life-threatening, feelings, says the FDA.
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.
Researchers at the University of Miami reported on Thursday what they believe are the first two confirmed cases in which the SARS-CoV-2 virus crossed a mother’s placenta and caused brain damage in the infants they were carrying.
Spain’s parliament passed a sexual and reproductive health law that allows girls aged 16 and 17 to undergo abortions without parental consent and, in a first for a European country, offers state-funded paid leave for women who suffer from painful periods.
An experimental COVID-19 vaccine in the form of an oral tablet has shown promising immune responses in a small preliminary trial designed mainly to evaluate its safety; High blood pressure more than doubles the risk of hospitalization during COVID-19 infections with the coronavirus Omicron variant, even in people who are fully vaccinated and boosted, a U.S. study showed.