Drug Approval | May 04, 2022
Gland launches Bortezomib in the US market
Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma
Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma
Three RFPs now open for qualified researchers through NORD's Jayne Holtzer rare disease research grants program
The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023
Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks
Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers
Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)
Desidustat is currently approved only in India as OxemiaTM for patients with CKD induced anemia
The tablets are available in 100 mg strength in bottle count sizes of 60
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
The company also plans to expand the facility
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