The first US clinical trial to assess the efficacy and safety of an investigational broad-spectrum antiviral agent, remdesivir (Gilead Sciences, Inc.), for the treatment of coronavirus disease 2019.
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The Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection; Astellas Pharma) for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients aged <4 months.
The use of e-cigarette products has been associated with several cases of severe pulmonary disease, according to the Centers for Disease Control and Prevention (CDC). In an official health advisory, the CDC stated that 215 possible cases have been reported across 25 states, with additional suspected cases still under investigation. One death has also been…
The patient, who had a history significant for cerebral palsy, seizures, and chronic constipation, had presented complaining of 3 days of fever, nausea, vomiting, and anorexia.
A recently published case report describes the case of a 36-year-old male chronic heart failure patient who, “spontaneously expectorated an intact cast of the right bronchial tree,” following an extreme bout of coughing.
The FDA has approved the supplemental new drug applicationfor Orfadin (nitisinone capsules; Sobi) which allows for an extension of shelf life for the 20mg capsules from 24 months to 36 months.
The Centers for Disease Control and Prevention (CDC) reported on a case where two patients presented to the emergency department in Contra Costa County, CA, suffering from a counterfeit Norco (hydrocodone, acetaminophen) intoxication.
The FDA has approved a supplemental new drug application (sNDA) for Delzicol (mesalamine) Delayed-Release Capsules for the treatment of mildly to moderately active ulcerative colitis in patients ≥5 years of age.
The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Pentasa (mesalamine; Shire) regarding an update to its route of administration.