We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
This edition of Quick Notes looks at the first nonsteroidal oral med for Duchenne muscular dystrophy, expanded indications for a cardiovascular risk reduction drug, an oncology approval, two Complete Response Letters for trial enrollment, and a combo pill for pulmonary hypertension. Read More
This edition of Quick Notes reviews four CHMP positive opinions, including a once-weekly insulin treatment for patients with type 2 diabetes, an oral monotherapy for patients with a rare blood disease, a new antibiotic to treat multi-drug resistant bacteria, and a generic multiple sclerosis drug treatment. Read More
Although less enthusiastic about Bristol Myers Squibb’s Abecma, the committee agreed by a vote of 8-3 that its benefit outweighed its risks in treating multiple myeloma. Read More
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