USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials

Asahi Kasei Pharma files application for approval to manufacture and sell Cresemba Capsule

The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients

Roche and Alnylam report positive topline results from Phase 2 study KARDIA-1 of zilebesiran

Zilebesiran demonstrated an encouraging safety and tolerability profile in adult patients with mild-to-moderate hypertension

Caplin Steriles receives EIR from US FDA

The inspection classification was determined by the agency as Voluntary Action Indicated

USFDA accepts biologics license application for GC Biopharma's GC5107B

Adlib and Generis launch software connector to increases automation and compliant management of document repositories

CARA is a data and content management platform that helps companies in regulated industries such as finance, energy, and manufacturing transform their complex business processes

Astellas receives FDA priority review for Zolbetuximab biologics license application

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients

Aurobindo's subsidiary to withdraw application for EU marketing authorization of two biosimilars

This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA