Pink SheetFrank Young, the first and only former commissioner of the US Food and Drug Administration to successfully manage and submit a new drug application after leaving the agency, passed away late on 24 Nov
Pink SheetOrphan drug designation for Indivior PLC ’s Sublocade (buprenorphine extended-release) was improperly granted 25 years ago under the Orphan Drug Act’s cost recovery provision and should be revoked, t
Pink SheetThe US Food and Drug Administration must set forth a standard by which a drug’s “innovation” is defined in determining whether Hatch/Waxman new product exclusivity blocks approval of a subsequent prod
Pink SheetThe US Food and Drug Administration's accelerated approval of Karyopharm Therapeutics Inc. 's Xpovio (selinexor) made headlines during the past few weeks over possibility that the agency backed the d