New Global Coalition Aims to Improve Access to Cancer Medicines

May 28th 2022

The Access to Oncology Medicines Coalition brings together phamra companies and other organizations to help countries develop the capacity and access to essential cancer medicines.

FDA Approves Amneal’s Biosimilar of Neulasta

May 27th 2022

This is the fifth biosimilar of Neulasta and the third biosimilar from Amneal to receive FDA approval.

FDA Accepts NDA for Omaveloxolone for Friedreich’s Ataxia

May 27th 2022

The FDA has assigned a Prescription Drug User Fee Act target action date of Nov. 30, 2022. Regulators indicated they plan to hold an advisory committee meeting to discuss the application.

FDA Approves Tibsovo Combination for Older Patients with Leukemia

May 26th 2022

Tibsovo is the first therapy targeting cancer metabolism for patients with newly diagnosed IDH1-mutated acute myeloid leukemia.

FDA Issues Second CRL for Poxvirus Treatment

May 26th 2022

Deficiencies at the contract manufacturing company are, for the second time, holding up approval of VP-102 to treat molluscum contagiosum, a mild skin infection.