Articles

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. 

Best Read Articles on FDA News in 2021

The FDA has set a Prescription Drug User Fee Act goal date of Sept. 28, 2022.


Monoclonal Antibody for Relapsing MS on the Way

Dr. Reddy’s launches generics of Diovan and venlafaxine ER, Apotex launches generic atropine sulfate solution, and Teva launches generic of Epiduo Forte.


 Generics Recently Launched

The broader indication for Zynrelef now covers around 7 million procedures annually and reduces the need for post-surgery opioids.

FDA Significantly Expands Indication for Zynrelef Analgesia

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com


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.



FDA Committee Votes No on Bardoxolone for CKD


The FDA in late November authorized the COVID-19 booster for all people 18 years of age and older.


Pfizer/BioNTech COVID-19 Booster EUA Expanded to Ages 16 to 17

Evusheld is the only monoclonal antibody authorized in the United States for COVID-19 pre-exposure prophylaxis.


FDA Grants Emergency Use of AstraZeneca’s COVID-19 Prevention Med


The oral granules formulation allows it to be used with soft foods and with feeding tubes.


FDA Approves Therapy for Multiple Sclerosis-Related Spasticity

Both Copiktra and Farydak had received accelerated approvals, and the FDA had required confirmatory trials. Secura Bio has determined such trials are not feasible.



Secura Bio Withdraws U.S. Oncology Indications for Copiktra, Farydak

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.
