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Lenmeldy (atidarsagene autotemcel) manufacturer Orchard Therapeutics received approval from the FDA as the first gene therapy indicated for the treatment of children with pre-symptomatic late infantile/early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Read More
Despite a potential increase in the risk of death, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted Friday in support of two already approved multiple myeloma CART-T cell treatments in earlier stages of the disease. Read More
The FDA has issued a final guidance on the process generic drug manufacturers can use to correspond with the agency on generic drug development, the agency’s process for responding and for manufacturers to clarify ambiguities in what the FDA refers to as “controlled correspondence.” Read More
The FDA’s approval on Thursday of Madrigal Pharmaceutical’s Rezdiffra (resmetirom) is the first for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis). Read More
This edition of Quick Notes reviews Wegovy’s new approval for cardiovascular event prevention, interchangeable approvals for biosimilars for Prolia and Xgeva, Biocon and Janssen’s settlement agreement for a Stelara biosimilar, and a Regeneron drug for inherited high cholesterol in children. Read More
Real-time communication between sponsors and regulators is a top priority for Nicole Verdun, the recently installed Super Office director for the Office of Therapeutic Products (OTP). Read More
Rather than handing out the approval Lilly was hoping for, the FDA will put donanemab, the company’s antiamyloid contender, through its paces in an upcoming advisory committee meeting. Read More
On Tuesday, the FDA’s Medical Imaging Drug Advisory Committee (MIDAC) green lighted Lumicell’s device-injection combo product aimed at helping surgeons detect residual breast cancer in breast tissue after lumpectomies. Read More
The FDA met its March 5 deadline to provide Vanda Pharmaceuticals with the details of its decision to deny the company’s request for a hearing on an sNDA for a jet lag disorder treatment, finding “that there is no genuine and substantial issue of fact justifying a hearing.” Read More