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© 2022 MJH Life Sciences and Formulary Watch. All rights reserved.
© 2022 MJH Life Sciences™ and Formulary Watch. All rights reserved.
December 26, 2021
The FDA's warning about Xeljanz (tofacitinib) and other JAK inhiitors and the extension of its review of Janssen's CAR T therapy for multiple myeloma were among the best read articles about the agency in 2021.
December 21, 2021
The FDA has set a Prescription Drug User Fee Act goal date of Sept. 28, 2022.
December 18, 2021
Dr. Reddy’s launches generics of Diovan and venlafaxine ER, Apotex launches generic atropine sulfate solution, and Teva launches generic of Epiduo Forte.
December 16, 2021
The broader indication for Zynrelef now covers around 7 million procedures annually and reduces the need for post-surgery opioids.
December 10, 2021
The regulatory agency is reviewing Reata’s application of bardoxolone to treat patients with chronic kidney disease caused by Alport syndrome, a rare genetic disease.
December 09, 2021
The FDA in late November authorized the COVID-19 booster for all people 18 years of age and older.
Evusheld is the only monoclonal antibody authorized in the United States for COVID-19 pre-exposure prophylaxis.
The oral granules formulation allows it to be used with soft foods and with feeding tubes.
December 06, 2021
Both Copiktra and Farydak had received accelerated approvals, and the FDA had required confirmatory trials. Secura Bio has determined such trials are not feasible.
December 04, 2021
The approval marks the ninth indication for Darzalex Faspro, the only subcutaneous anti-CD38 monoclonal antibody approved to treat multiple myeloma across multiple treatment regimens.