Top Regulatory News Stories – Week Ending August 16, 2019

Harmony Biosciences announced today that the FDA approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).  https://finance.yahoo.com/news/harmony-biosciences-announces-fda-approval-120000845.html The FDA has approved[…]

Top Regulatory News Stories – Week Ending August 9, 2019

Daiichi Sankyo announced that the US FDA approved TURALIO™ (pexidartinib) as the first and only treatment for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery.  https://www.prnewswire.com/news-releases/fda-approves-daiichi-sankyos-turalio-pexidartinib-for-the-treatment-of-select-patients-with-tgct-a-rare-and-debilitating-tumor-300895924.html Last week the FDA approved Bayer’s Nubeqa® (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer.[…]

Top Regulatory News Stories – Week Ending August 2, 2019

Celgene received FDA approval for Otezla to treat oral ulcers associated with Behçet’s Disease. https://www.pharmaceutical-business-review.com/news/celgene-otezla-behcets-disease/ Apic Bio, Inc. announced that the FDA has granted orphan drug designation to APB-102, a gene therapy soon to be in clinical development for the treatment of genetic SOD1 amyotrophic lateral sclerosis (ALS).  http://www.firstwordpharma.com/node/1654288#axzz5uQCOiPcE Biohaven Pharmaceuticals reported that the FDA[…]

Top Regulatory News Stories – Week Ending July 19, 2019

Cellectar Biosciences announced the FDA has granted Fast Track Designation for CLR 131 in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL).  https://www.globenewswire.com/news-release/2019/07/09/1880139/0/en/Cellectar-Receives-FDA-Fast-Track-Designation-for-CLR-131-in-Diffuse-Large-B-Cell-Lymphoma.html Dicerna Pharmaceuticals announced that the FDA has granted a Breakthrough Therapy Designation (BTD) to DCR-PHXC for the treatment of patients with primary hyperoxaluria type 1 (PH1). https://www.businesswire.com/news/home/20190715005117/en/Dicerna-Receives-Breakthrough-Therapy-Designation-DCR-PHXC-Treatment/?feedref=JjAwJuNHiystnCoBq_hl-WFAllVCLJFCqzlmaJ8DKHU4plfPZtlGYRDUHCSmgbii6XkLWuQZD-HgGRnjQvCyg3iCfEFIaJW7-otp9V1XQiK2eHTJy3ZqOEt7kKgLu20J Neurocrine Biosciences said the FDA[…]

Top Regulatory News Stories – Week Ending July 12, 2019

Karyopharm Therapeutics announced that the U.S. FDA has approved oral XPOVIOTM (selinexor), a nuclear export inhibitor, in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). https://www.globenewswire.com/news-release/2019/07/03/1878060/0/en/Karyopharm-Announces-FDA-Approval-of-XPOVIO-selinexor-for-the-Treatment-of-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma.html Alexion’s Soliris received FDA approval for an additional indication last week.  The drug is now approved to treat neuromyelitis optica spectrum[…]

Top Regulatory News Stories – Week Ending June 27, 2019

AMAG Pharmaceuticals announced that the U.S. FDA has approved Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. https://www.amagpharma.com/news/amag-pharmaceuticals-announces-fda-approval-of-vyleesi-bremelanotide-injection-for-acquired-generalized-hypoactive-sexual-desire-disorder-hsdd-in-premenopausal-women/ Alexion’s drug Ultomiris has snagged a priority review from the FDA to treat atypical hemolytic uremic syndrome (aHUS), an ultra-rare disease that can cause progressive damage[…]