Submissions and Approvals

Pfizer’s MabThera Biosimilar Nabs European Approval

April 3, 2020

Ruxience was recently made available to adults in the U.S. for several of the same indications and launched in Japan in January. Read More

FDA Approves Sevenfact for Hemophilia

April 2, 2020

Sevenfact’s active ingredient is an analog of human coagulation factor FVII expressed in the mammary gland of genetically engineered rabbits. Read More

Bayer’s Nubeqa Grabs EC Approval for Prostate Cancer

March 31, 2020

The drug is currently approved in five other countries including the U.S. Read More

CHMP Recommends Gene Therapy Zolgensma and Seven Other Drugs

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended AveXis’ spinal muscular atrophy gene therapy Zolgensma along with seven other medicines at its March meeting. Read More

Vertex to Pause Some Clinical Trials Due to COVID-19

March 27, 2020

Vertex said that the outbreak has not had any impact on its supply chain. Read More

Gilead’s Epclusa Approved for Hepatitis C in Children

March 26, 2020

The drug is currently indicated in combination with ribavirin to treat pediatric patients six years and older or weighing at least 37 pounds with severe cirrhosis. Read More

Bristol-Myers Squibb Says MS Drug Launch Delayed due to COVID-19

March 26, 2020

Zeposia was approved for treating adults with relapsing forms of multiple sclerosis. Read More

Gilead Withdraws Orphan Drug Status for Remdesivir

In a surprise move based on public outcry, Gilead asked the FDA to rescind remdesivir’s orphan drug designation as a potential COVID-19 treatment. Read More