Regulatory
Sprout wanted the warning regarding alcohol to be completely removed but the FDA said it must remain, although with a caveat.
Pharma and biotech companies from Asia to Europe provide updates on business and clinical activities.
With the ever-rising concerns over the costs of various prescription medications, a report from consumer pharmaceutical watchdog group Institute for Clinical and Economic Review released a report questioning the potential pricing of two yet-to-be-approved peanut allergy treatments.
The agency approved Evenity on the basis of two Phase III clinical trials. The drug had been rejected in 2017 over safety concerns.
PhaseBio Pharmaceuticals, based in Malvern, Penn. and San Diego, announced that its antiplatelet drug PB2452 had received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
Zogenix said the FDA determined that the NDA, which was submitted in February, was not “sufficiently complete to permit a substantive review.”
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Dovato, a once-a-day, single-tablet combination of dolutegravir (DTG) and lamivudine (3TC) for HIV-1 in adults who had not received treatment before.
Eisai Co., Ltd. has announced that its in-house discovered fibroblast growth factor receptor tyrosine kinase inhibitor E7090 has been granted the SAKIGAKE designation by Japan’s Ministry of Health, Labour and Welfare for the treatment of unresectable biliary tract cancer with FGFR2 gene fusion.
Celgene and its developmental partner Acceleron Pharma are eying a potential U.S. Food and Drug Administration approval of a blood-disease treatment.
The FDA calendar has only one PDUFA data scheduled for the next couple weeks. On Thursday, April 11, the U.S. Food and Drug Administration (FDA) and Merck & Co. have a target action date for their supplemental Biologics License Application (sBLA) for Keytruda
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