FDA slow walking a long-awaited abortion pill safety study

The Food and Drug Administration has delayed a promised review of safety data for the abortion drug mifepristone at ...
Ophthalmology Times

FDA extends Aldeyra's reproxalap PDUFA after requesting additional clinical study report

The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for Aldeyra’s New Drug Application (NDA) for reproxalap for the treatment of dry ...
STAT

FDA to lower number of trials required for approval of drugs, other medical products

The FDA plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration ...
BioSpace

FDA’s ‘Conundrum’: What To Do With Approved Drugs That Fail Pivotal or Confirmatory Trials

With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former ...
BioSpace

J&J Wins Proactive FDA National Priority Voucher for Multiple Myeloma Combo

Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a ...
WSB-TV

FDA study suggests compounded hormones are risky, concerning patients, pharmacists

COBB COUNTY, Ga. — A warning to women who rely on compounded hormones to deal with menopause and other health issues: A study shows the drugs are risky because they’re not regulated by the Food and ...