Regulatory Authority Actions

Ashland Injectable Pharmaceutical Excipient Accepted into FDA Novel Excipient Review Pilot Program

November 01, 2022

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

FDA Embroiled in Reproductive Rights Debate

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.

FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment

October 26, 2022

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

Pressure Mounts for FDA to Reform Accelerated Approval Program

October 26, 2022

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.

WHO Ranks South Africa’s Vaccine Regulatory System at a Functional Level of Maturity

October 26, 2022

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

EMA Extends Use of COVID-19 Vaccines to Children

October 21, 2022

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

EMA Recommends Adapted Spikevax Vaccine

October 21, 2022

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

Post-Transplant Lymphoproliferative Disease Treatment Receives Marketing Authorization Recommendation from EMA

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.

EMA Announces Positive Indication for Takeda’s Dengue Vaccine

October 19, 2022

Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.

FDA Authorizes Bivalent COVID-19 Boosters for Children Ages Five 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.