Korsuva FDA Approved
The U.S. Food and Drug Administration (FDA) approved KorsuvaTM (difelikefalin) injection. The first drug in a new therapy class called kappa opioid receptor (KOR) agonists, it’s also the first drug to be indicated for treating adults who have moderate-to-severe pruritus (chronic itching) associated with chronic kidney disease (CKD) that needs hemodialysis. Aug. 23, 2021
New Growth Hormone, Skytrofa, Approved
Ascendis Pharma received FDA approval for Skytrofa® (lonapegsomatropin- tcgd), a long-acting prodrug of human growth hormone. Aug. 25, 2021
New Opdivo Indication
Bristol Myers Squibb’s Opdivo® (nivolumab) injection became the first programmed death receptor-1 (PD-1) inhibitor to be FDA approved for adjuvant (after surgery) treatment of urothelial carcinoma (bladder cancer). Aug. 19, 2021
Expanded Indication for Xarelto
The peripheral artery disease (PAD) indication for Janssen and Bayer’s Xarelto® (rivaroxaban) tablets was extended by the FDA. Aug. 23, 2021
Tibsovo Gains a New Indication
Under Priority Review, the FDA approved Servier Pharmaceuticals’ Tibsovo® (ivosidenib) tablets as second-line or later treatment for adult patients who have metastatic or advanced isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (cancer in the bile ducts). Aug. 25, 2021
Labeling Change for Linzess
Ironwood Pharmaceuticals got FDA approval to revise the boxed warning for Linzess® (linaclotide) capsules. Aug. 24, 2021
New Gvoke Dosage Form Approved
Gvoke® Kit (glucagon) injection was FDA approved. Joining previously available dosage forms Gvoke HypoPen® and Gvoke® PFS, it is used for emergency treatment of patients two years old and older who have diabetes and who are at risk for hypoglycemic episodes. Aug. 20, 2021
Teligent Pharma – Recall of lidocaine topical solution
Teligent Pharma announced a voluntary, patient-level recall of one lot of lidocaine topical solution 4% because testing has found it to be super potent based on an out of specification result obtained at the 18-month stability timepoint. August 27, 2021