The U.S. Food and Drug Administration (FDA) declined to approve Verrica Pharmaceuticals Inc's drug for the treatment of a viral skin disease known as molluscum contagiosum, the company said on Tuesday.
Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew KellyMay 24 - The U.S. Food and Drug Administration declined to approve Verrica Pharmaceuticals Inc's
The disease is caused by a pox virus and leads to skin-toned to pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. While the lesions usually go away within a year without scarring, some cases could take a lot more time.Register now for FREE unlimited access to Reuters.
Verrica said it had been told that internal policy is preventing the health regulator from "communicating the label and approving the NDA " when a contract manufacturer is placed on OAI status.
Österreich Neuesten Nachrichten, Österreich Schlagzeilen
Similar News:Sie können auch ähnliche Nachrichten wie diese lesen, die wir aus anderen Nachrichtenquellen gesammelt haben.
Opinion | Why Is the FDA Seizing Baby Formula During a Baby Formula Shortage?From WSJopinion: The FDA’s actions have exacerbated the baby formula shortage problem they were trying to solve, write scottlincicome and emilyekins
Weiterlesen »
Jif peanut butter recall: Throw away these jars right now, FDA warnsThe J.M. Smucker Company, Jif peanut butter's parent company, has issued a nationwide recall of its product due to potential Salmonella contamination.
Weiterlesen »
U.S. FDA sets June meeting dates for Moderna, Pfizer small children COVID-19 vaccinesThe U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc's emergency authorization request for its COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc's vaccine for those aged 6 months through 4 years.
Weiterlesen »
Pfizer Says 3 COVID Shots Protect Kids Under 5, Will Soon Send Data to FDAThe 18 million kids under 5 are the only group in the U.S. not yet eligible for COVID-19 vaccination.
Weiterlesen »
FDA head grilled by members of both parties on baby formula shortage crisisFood and Drug Administration Commissioner Robert Califf took criticism from both Democrats and Republicans on a House subcommittee over the baby formula shortage on his watch that has left many parents desperate.
Weiterlesen »