Regulatory Oversight and Compliance

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.

Drug Solutions Podcast: Novel Excipients in Drug Development

October 18, 2022

In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.

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.

FDA Expands Oversight of Cell and Gene Therapies

October 12, 2022

CBER maps modernization plan to handle surge in research and applications.

UK Approves Treatment for Sleep Onset Insomnia in Children and Adolescents

October 06, 2022

The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.

FDA Grants Fast Track Designation to Cue Biopharma

October 04, 2022

FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma.

Biologic Standards in the Pharmacopoeias: An Update

October 02, 2022

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.

The Future of Pharmaceutical Environmental Monitoring in Europe

October 02, 2022

A blended approach to newly revised regulatory guidance to inform environmental monitoring programmes is essential.