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Over the past week, the FDA issued final guidances on direct-to-consumer promotional labeling and advertisements and treatment for chronic rhinosinusitis with nasal polyps. Draft guidances were issued on psychedelic drugs, orthopedic implants and wholesaling under section 503B. Read More
Panelists said that there are no currently approved targeted therapies and there exists a dire patient need for treatments, they were troubled by Ipsen’s pivotal late-stage study data. Read More
The FDA’s final guidance on developing drugs and biologics to treat chronic rhinosinusitis with nasal polyps shares considerations sponsors should make for trial design/population, safety, effectiveness, and statistical analysis. Read More
Eli Lilly announced Thursday that it will acquire the privately held biopharmaceutical company Sigilon Therapeutics with the goal of developing encapsulated cell therapies for the potential treatment of type 1 diabetes. Read More
The FTC and the DOJ are pushing for rules that would require companies planning a merger or acquisition to forestall consummation until federal agencies have had enough time to more deeply investigate whether the transaction would violate antitrust laws and “harm the American public.” Read More
A lack of conclusions or follow-up in written records of investigations into unexplained discrepancies since 2020 for Duopa Intestinal Gel (levodopa-carbidopa) prompted FDA investigators to issue a Form 483 to AbbVie’s North Chicago, Ill., facility following a Jan. 23-31 inspection. Read More
A June 22 FDA warning letter to API manufacturer Chengdu KeCheng Fine Chemicals details an October 2022 conversation in which the firm’s general manager told the FDA that his company was not shipping products to the U.S. Read More
An FDA advisory committee voted 10 to 4 to recommend Ipsen Biopharmaceuticals’ palovarotene as an effective therapy for the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP), which causes tendons and ligaments to be replaced by bone. Read More
The FDA’s interpretation and policies on exemption as well as prohibition of wholesaling of compounded drugs in section 503B of the Food, Drug & Cosmetic Act (FDC) are explained in a draft guidance published on June 27. Read More
Receiving oncology study submissions that propose a too-wide range of types and formats of real world data (RWD) — along with a lack of basic elements of study design — has prompted the creation of the FDA’s new Oncology Quality, Characterization, and Assessment of Real-world Data (QCARD) Initiative. Read More
Upcoming events in the coming weeks include three FDA advisory committee meetings as well as webinars on the FDA's sterilization pilot and design control. Read More