FDA

The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer has been approved in the US.  The Food and Drug Administration (FDA) has approved Orserdu (elacestrant) for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with […]

Robust digital workflows can reduce errors and time to compile data leading to greater transparency, faster reporting and help biopharmaceutical companies reach regulatory submission faster. Ken Forman, Senior Director of Product Strategy, IDBS explains. For many start-ups operating on limited investment capital, the ticking clock can be overwhelming. Teams must plan for post-approval activities while […]

Intercept Pharmaceuticals’ obeticholic acid (OCA) could be first drug to be approved in the US for non-alcoholic steatohepatitis (NASH), according to analysts GlobalData.  The Food and Drug Administration (FDA) accepted the company’s resubmission of its new drug application (NDA) for OCA in patients with pre-cirrhotic liver fibrosis due to NASH in December 2022.  According to […]

Dr Julie Warner is Vice President of Regulatory Affairs at global drug development consultancy, Boyds. In this article, she provides her expert insights into the key regulatory developments likely to shape the global drug development industry this year.    Implementation of the EU Clinical Trials Regulation  The way clinical trials (CTs) are conducted in the European […]

The US Food and Drug Administration (FDA) and CN Bio have expanded their collaboration for the second time, with new research aiming to evaluate multi-organ microphysiological systems (MPS) using the PhysioMimix Multi-organ System.   The system will initially be investigated for improving the preclinical estimation of human drug bioavailability compared to standard animal models.  Dr Emily […]

Leqembi’s prospects in the Alzheimer’s disease market remain uncertain despite its advantages over Aduhelm, says analytics company GlobalData.  Eisai and Biogen’s anti-amyloid beta (Aβ) monoclonal antibody (mAb), Leqembi (lecanemab), recently gained approval from the Food and Drug Administration (FDA) under the accelerated approval pathway for the treatment of Alzheimer’s disease (AD) in patients with early […]

Airsupra (albuterol/budesonide) has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.  Airsupra is a pressurised metered-dose inhaler (pMDI), fixed-dose combination of albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS). It […]

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for VAX-24, Vaxcyte’s 24-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease.  The decision was based on positive topline results from a Phase I/II proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of VAX-24 in adults 18-64 years of age.  […]

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation for iOnctura’s IOA-244, which is in development for solid and hematologic malignancies including uveal melanoma.  Uveal melanoma is a disease in which cancer originates in the tissues of the eye, causing symptoms such as blurred vision or a dark spot on the iris.   […]

The United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Bicycle Therapeutics’ BT8009 monotherapy for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer.   BT8009 is a potential first in class Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a protein that is highly expressed in urothelial […]