Regulatory Filings and Submissions

New Drug Approvals on Track at FDA

July 30, 2021

In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.

CHMP to Assess Extended Indication of Kineret for COVID-19

July 29, 2021

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

FDA Approves Merck’s 15-Valent Pneumococcal Vaccine

July 27, 2021

Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.

FDA Approves Amneal’s Generic Version of TobraDex

July 27, 2021

Amneal Pharmaceuticals received ANDA approval from FDA for the generic version of TobraDex.

Sinovac’s Eupolio Vaccine Gains Market Authorization in China

July 22, 2021

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

EC Grants Marketing Authorization for bluebird bio’s Gene Therapy SKYSONA

July 22, 2021

The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD.

Samsung Biologics Partners with Kineta for Anti-VISTA Antibody Immunotherapy

July 21, 2021

Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic.

FDA Clears Tevogen Bio’s IND Application for CTL COVID-19 Treatment

July 13, 2021

The IND for Tevogen Bio's TVGN-489, an allogeneic COVID-19-specific cytotoxic T lymphocyte, received rapid clearance from FDA.

FDA Grants Priority Review for AstraZeneca Asthma Biologic

July 09, 2021

Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.

MHRA Gives Diurnal the Nod for Efmody

July 08, 2021

MHRA has granted marketing authorization for Diurnal Group’s Efmody as a treatment of adult and adolescent patients with CAH in Great Britain.