UK’s NICE Issues Draft ‘No’ Decision for Sarclisa Triple Combo
The U.K.’s National Institute for Health and Care Excellence (NICE) has issued a draft “no” statement on the triple combination of Sarclisa (isatuximab),…
Myeloma
Xpovio Triple Combo Before FDA for Previously Treated Myeloma Patients
Karyopharm Therapeutics is asking that Xpovio (selinexor) be approved with Velcade (bortezomib) and low-dose dexamethasone to treat people with multiple myeloma…
New Under-the-skin Darzalex Formulation Approved in EU
The European Commission (EC) has approved a new under-the-skin (subcutaneous), fixed-dose formulation of Janssen’s Darzalex (daratumumab) for the treatment of adults…
Sarclisa Triple Combo Approved in Europe for Advanced Myeloma Patients
The European Commission (EC) has approved Sanofi‘s Sarclisa (isatuximab), in a triple combination with Pomalyst (pomalidomide) and dexamethasone, to treat adults…
CHMP Favors Darzalex Faspro in Treating Patients in EU
Janssen‘s new under-the-skin formulation of daratumumab, called Darzalex Faspro, has been recommended for approval…
FDA Asks for More Data on Ide-cel as Potential Multiple Myeloma Therapy
The U.S. Food and Drug Administration (FDA) asked for more information from Bristol Myers Squibb and Bluebird Bio as it considers a…
Cell Protein Analysis May Predict Multiple Myeloma Response to Treatment
A new technology that measures the levels of proteins in individual cells could help to identify therapy combinations that might more effectively treat people with …
FDA Approves Darzalex Faspro as Injection Therapy for Multiple Myeloma
The U.S. Food and Drug Administration (FDA) approved Janssen‘s new formulation of daratumumab — a subcutaneous or under-the-skin injection treatment called Darzalex Faspro…
Actemra May Treat Severe COVID-19 Infections in Myeloma Patients, Case Report Suggests
Actemra (tocilizumab), a medicine approved for certain types of arthritis, may be effective in treating severe infections with the new coronavirus in…
Industry leaders seek to advance innovative resources for rare and orphan disease communities amid COVID-19 outbreak
FFF Enterprises and Bionews announced today that both rare and orphan disease advocates are joining forces to provide patients with resources to help them connect…
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