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© 2021 MJH Life Sciences and Formulary Watch. All rights reserved.
© 2021 MJH Life Sciences™ and Formulary Watch. All rights reserved.
October 19, 2021
COVID-19 travel restrictions have hindered the FDA’s ability to inspect European manufacturing facilities for bimekizumab, which is under review for the treatment of patients with psoriasis.
ZIMHI is the second product approved by the FDA to counteract opioid, and it is a high-dose naloxone expected to be launched in the first quarter of 2022.
This low-dose formulation of Biktarvy is for younger children living with HIV.
October 18, 2021
Narsoplimab was under review at the FDA to treat a complication of stem cell transplants.
The agency cited an open inspection issue at a facility that performs analytical testing of drug substance.
Tyrvaya is a twice daily nasal spray, a first for the treatment of dry eye disease.
The FDA approved Lybalvi in June 2021 to treat schizophrenia and bipolar disorder.
October 17, 2021
Boehringer Ingelhiem will make Cyltezo available when its commercial license begins on July 1, 2023.
October 15, 2021
Submission is based on extrapolation analysis and results examining the effects of Rexulti in treating symptoms of schizophrenia in patients 13 to 17 years old. The FDA is expected to complete its review in December 2021.
The FDA has assigned a target action date of April 13, 2022, and plans to hold an advisory committee meeting.