Page 102 - Priority Review News Today

– Mosunetuzumab could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin’s lymphoma – – Application is... | July 6, 2022

Aura Biosciences, Inc. , a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate therapies for multiple oncology indications, today announced that the U.S. Food... | June 30, 2022

(RTTNews) - The U.S. Food and Drug Administration has accepted for Priority Review Ipsens (IPSEY) resubmitted New Drug Application or NDA for in...

The FDA has issued a Complete Response Letter regarding the New Drug Application for tebipenem HBr for complicated urinary tract infections.

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its resubmitted New Drug Application (NDA) for

The approval expands the indication to include use of the drug after the failure of first-line therapy.

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients Priority Review requested; if accepted, anticipate an 8-month FDA review Positive EMERALD study data previously announced on October 20, 2021 First, and currently only, investigational oral SERD with positive topline results Additional data presented at SABCS (December 2021) and ASCO (June 2022) Plan to file marketing authorization application for elacestrant in the EU in 2H 2022 FLORENCE, Italy and BOSTO...

VBI Vaccines Receives U.S. FDA Orphan Drug Designation for VBI-1901 for the Treatment of Glioblastoma - FDA Orphan Drug... | June 22, 2022

On Wednesday, the FDA approved Merck's pneumococcal 15-valent conjugate vaccine for children 6 weeks through 17 years of age.

Increasing prevalence of Pompe Disease is one of the key factors driving Pompe Disease market revenue growth