Regulation

FDA grants expanded approval for GSK’s ovarian cancer drug Zejula

GlaxoSmithKline (GSK) has secured expanded approval from the US Food and Drug Administration (FDA) for its Zejula (niraparib) for the late-line treatment for women with recurrent ovarian cancer.

FDA grants fast track status to Moderna’s mRNA therapeutic to treat propionic acidemia

Moderna has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational messenger RNA (mRNA) therapeutic, called mRNA-3927, to treat propionic acidemia (PA).

FDA approves TRIKAFTA to treat the underlying cause of cystic fibrosis

Vertex Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation.

Alexion receives FDA approval for ULTOMIRIS for atypical hemolytic uremic syndrome

Alexion Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved ULTOMIRIS (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) for adult and pediatric (one month of age and older) patients.

FDA approves AstraZeneca’s Farxiga to treat heart failure in diabetic patients

AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.

Trastuzumab deruxtecan granted FDA priority review to treat patients with HER2-positive metastatic breast cancer

AstraZeneca and Daiichi Sankyo announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted priority review.

FDA approves Roche’s Xofluza for patients at high risk of developing flu-related complications

Roche has secured approval from the US Food and Drug Administration (FDA) for its Xofluza (baloxavir marboxil) to treat people at high risk of developing influenza-related complications.

Janssen, Bayer get FDA nod for Xarelto to prevent VTE in acutely ill medical patients

Bayer and Janssen Research & Development have secured approval from the US Food and Drug Administration (FDA) for Xarelto (rivaroxaban) to prevent blood clots in acutely ill medical patients.

Eli Lilly gets FDA approval for migraine drug Reyvow

Eli Lilly has secured approval from the US Food and Drug Administration (FDA) for its Reyvow (lasmiditan) for the acute treatment of migraine.