Home Stock FDA rejects Mesoblast’s cell remedy for bone marrow transplant problems By Reuters

FDA rejects Mesoblast’s cell remedy for bone marrow transplant problems By Reuters

0
FDA rejects Mesoblast’s cell remedy for bone marrow transplant problems By Reuters

[ad_1]


© Reuters. FILE PHOTO: Signage is seen exterior of the Meals and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Picture/File Picture

(Reuters) – The U.S. Meals and Drug Administration had rejected Mesoblast (NASDAQ:)’s cell remedy for kids beneath 12 years of age for treating a sort of complication that happens after a stem cell or bone marrow transplant, the corporate stated on Thursday.

The well being regulator required extra information to assist advertising approval for the corporate’s lead product remestemcel-L, Mesoblast stated in an announcement.

The rejection offers a blow to Mesoblast’s hopes for a possible launch of the remedy, particularly after its fundraising efforts during the last two years.

The drug developer was looking for the FDA’s approval for a cell remedy to deal with youngsters with a sort of graft versus host illness (GvHD), whose signs didn’t reply to straightforward steroid remedy or developed recurrence whereas persevering with therapy.

There are not any accepted therapies in youngsters for the situation wherein the donor bone marrow or stem cells assault the recipient.

[ad_2]

LEAVE A REPLY

Please enter your comment!
Please enter your name here