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November 01, 2022
A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.
October 26, 2022
AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.
An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.
South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.
October 21, 2022
The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.
The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.
October 19, 2022
Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.
Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.
October 13, 2022
FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.
October 06, 2022
The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.