Regulatory Oversight and Compliance

FDA Grants EUA for Pfizer-BioNTech COVID-19 Vaccine Use in Children

November 01, 2021

The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.

Novavax Files for Authorization of its COVID-19 Vaccine in the UK and Australia

October 29, 2021

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.

CHMP Recommends Booster Dose Consideration for Moderna COVID-19 Vaccine

October 29, 2021

EMA’s CHMP concluded that a booster dose of Moderna’s Spikevax vaccine may be considered in people aged 18 and older.

FDA Approves Genentech’s Susvimo for Wet AMD

October 29, 2021

Genentech’s Susvimo (ranibizumab injection) is approved for intravitreal use via ocular implant for the treatment of neovascular age-related macular degeneration.

Otsuka Applies to EMA for Marketing Authorization of Vadadustat

October 29, 2021

Otsuka has submitted an initial marketing authorization application to EMA for vadadustat as a treatment of anemia associated with CKD in adults.

NIH and FDA Lead Coalition to Accelerate Gene Therapy Development for Rare Diseases

October 29, 2021

The National Institutes of Health (NIH), FDA, and fifteen private organizations are partnering together to form the Bespoke Gene Therapy Consortium.

MHRA Grants License to Gedeon Richter for Combination Therapy to Treat Uterine Fibroids

October 29, 2021

MHRA has granted a license to Gedeon Richter for Ryeqo to treat moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

FDA Advisory Committee Votes in Favor of EUA for Pfizer-BioNTech COVID-19 Vaccine in Children

October 29, 2021

The panel voted 17 to 0 to recommend that FDA grant Emergency Use Authorization for Pfizer-BioNTech’s COVID-19 vaccine in children aged 5 to 11 years old.

FDA Acknowledges Hurdles in Utilizing Real-World Data

October 28, 2021

FDA has worked to clarify how drug development can gain from tapping into information in health care systems and claims databases.

Bristol Myers Squibb Receives European Commission Approval for Opdivo

October 22, 2021

The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.