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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
In a 12 to 2 vote Thursday, an FDA advisory committee gave a thumbs up to Geron Corporation’s imetelstat for treating transfusion-dependent (TD) anemia in adults with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS), who are ineligible or don’t respond to erythropoiesis-stimulating agents (ESAs). Read More
Over the past week, the FDA issued final guidance on assessing COVID-19 symptoms in adult and adolescent clinical trial subjects. Draft guidances were issued covering drug development for early onset Alzheimer’s disease, labeling changes for nonprescription drug NDAs and ANDAs, updates for the premarket cybersecurity guidance, E2D(R1) postapproval safety data, thermal effects of tissue heating and/or cooling medical devices and the Q-Submission program. 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
Stool for Fecal Transplants Company Earns FDA Warning Letter
Teaser: The Warning Letter confirms that the organization must have an FDA-approved BLA confirming the product is safe, pure and potent. Read More
The FDA’s legislative wish list for FY 2025 includes proposals to protect drug supply resiliency, amend the Hatch-Waxman Act, and exercise greater control over recalls. Read More
Last month, signs that magrolimab increases the risk of death prompted Gilead to shelve the drug for blood cancer, Vertex’s second-gen cystic fibrosis combo leaves the company’s first-gen efforts in the dust, a new drug combo looks promising for multiple myeloma, and Regenxbio hopes to snag an Accelerated Approval for a new rare disease gene therapy. Also, Astra Zeneca is touting “major advance” in treating one type of non-small cell lung cancer. Read More
Par Pharmaceutical, a subsidiary of Endo International, announced a voluntary recall of one lot of treprostinil injection 20mg/20mL due to the potential for the presence of silicone particulates in the product solution. Read More
Human Microbes, a company promoting the value and sale of fecal microbiota transplants (FMT), has received an FDA Warning Letter listing a litany of regulatory violations, including lack of an FDA-approved BLA. Read More
The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) program is a great start for encouraging industry to develop these systems but it needs a lot more detail before businesses will wholeheartedly embrace it, according to stakeholder comments. Read More