Food and Drug Administration (FDA)
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Hookipa Biotech and Gilead inked a research collaboration deal to develop and commercialize therapeutics for hepatitis B (HBV) and HIV.
The U.S. Food and Drug Administration (FDA) approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s Neulasta (pegfilgrastim). The biosimilar was co-developed with Biocon.
Portola Pharmaceuticals’ chief executive officer, William Lis, plans to retire as both chief executive and board member.
Horizon Pharma and the National Organization for Rare Disorders (NORD) launched a new campaign today that recognizes innovation in rare disease therapeutics since the passing of the Orphan Drug Act in 1983.
The ink is barely dry on the recently-passed “Right to Try Act,” and the law’s author, Sen. Ron Johnson (R-Wis.) and U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb are butting heads.
FDA Commissioner Scott Gottlieb released a statement on new policies aimed to combat the practice of using certain agency requirements to block timely generic drug entry.
It’s been a busy week for Nektar Therapeutics with the announcement of an NDA submission to the FDA for NKTR-181 and a non-exclusive, clinical collaboration deal with Syndax Pharmaceuticals.
Shares of CRISPR Therapeutics plunged dramatically Wednesday after the U.S. Food and Drug Administration placed a clinical hold on a planned sickle cell disease treatment the company was in the process of developing with Vertex Pharmaceuticals.
With the ever-increasing concerns of the opioid crisis facing the United States, the U.S. Food and Drug Administration has launched an “innovation challenge” to spur on the development of medical devices that can combat the crisis and help prevent and treat opioid use disorder.
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