The FDA’s Peripheral and Central Nervous System Drugs advisory committee will discuss the merits of Biogen and Ionis’s ALS candidate tofersen on March 22nd.
To further support pharma manufacturing partners and ensure launch delays are avoided, the company has deepened its expertise with REMS Strategy and Project Management solutions.
Ardelyx, Inc. announced that the Office of New Drugs (OND), Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) granted the appeal to the Complete Response Letter (CRL) for the New Drug Application (NDA) for XPHOZAH
In a head-to-head comparison trial, BeiGene’s Brukinsa (zanubrutinib) bested Janssen’s Imbruvica (ibrutinib) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.
On Nov.16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to assess the data supporting Ardelyx’s New Drug Application for tenapanor in chronic kidney disease.
The U.S. Food and Drug Administration on Friday extended for the second time its review of Amicus Therapeutics Inc.’s experimental combination therapy to treat a muscle disorder called Pompe disease.
Ipsen’s fibrodysplasia ossificans progressiva (FOP) odyssey continues as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.
The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.
Blueprint Medicines’ Ayvakit (avapritinib) is headed to the FDA for a new indication after the drug hit the mark in Part 2 of the PIONEER trial for non-advanced systemic mastocytosis.