FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer

Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population

FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma

Iberdomide has the potential to be the first approved CELMoD agent

FDA grants priority review to Tzield for youngest Type 1 diabetes patients

Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D

FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care

EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease

Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD

US District Court grants summary judgement in Favour of SPARC for Sezaby PRV

FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

HER2-mutant NSCLC typically has a poor prognosis and limited treatment options

FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma

Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition

FDA grants breakthrough status to Augurex’s SPINEstat test to advance early axSpA diagnosis

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability