Drugs
An 8/18-8/22/2025 FDA inspection at the HTO Nevada drug manufacturing facility doing business as Kirkman in Lake Oswego, OR, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/27 Warning Letter says the specific violations were: * failure of the
Drugs
FDA has released the form FDA-483 with 12 observations from a 9/18-9/26/2025 inspection at the Baxter Oncology drug manufacturing facility in Halle, North Rhine-Westphalia, Germany. The specific observations were: * failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile,
FDA Policy/General
FDA has released a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The document applies to devices with cybersecurity considerations, including but not limited to those that have a device software function or that contain software (including firmware) or programmable logic, and it
Drugs
Rep. Jake Auchincloss (D-MA) says the FDA Commissioner’s National Priority Voucher (CNPV) program may not be legal since it was created by the agency itself and not by Congress. The Associated Press reports that Auchincloss wrote to FDA asking that it affirm or refute his concerns about the
Biologics
FDA is signaling a supportive but cautious regulatory posture toward the development of chimeric antigen receptor (CAR) T-cell therapies for autoimmune and rheumatic diseases, according to a perspective article published in the Annals of Internal Medicine by agency officials. CAR-T cell therapies — genetically engineered T cells programmed to
Devices
FDA has issued an early alert to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used to support patients with acute right heart failure. The alert, which applies to all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices, comes after Abiomed
FDA Policy/General
FDA deputy chief of staff Samuel Doran is the target of an HHS Office of Inspector General (OIG) ethics investigation on whether he misled the federal government by using a sham divorce to conceal potential conflicts of interest, according to a Bloomberg report. At issue is the relationship between Doran
Drugs
Florida remains the only state authorized by the Food and Drug Administration to import prescription drugs from Canada, but the long-promised program has yet to deliver any imported medicines more than two years after receiving final agency FDA approval. The state’s Section 804 drug importation initiative, championed by
Devices
FDA has issued Beta Bionics a Warning Letter following an inspection of the company’s Irvine, CA, facility conducted 6/2025, according to a company regulatory filing. The agency issued the letter 1/29 after reviewing the company’s responses to a Form 483 listing inspectional observations identified during the
Drugs
FDA has issued Pharming Group a complete response letter for its supplemental NDA (sNDA) seeking expanded approval of Joenja (leniolisib) for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS). The drug is currently approved for treating APDS in patients aged 12 years and older.
Drugs
FDA has issued Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating Type I allergic reactions, including anaphylaxis. FDA identified concerns in the product’s human factors validation study, including difficulty opening the pouch and incorrect placement of the sublingual film, which
Devices
A patient safety advocacy group has filed a citizen petition urging FDA to create a comprehensive public database of medical device labels, arguing that greater transparency is needed to support informed decision-making, research, and postmarket oversight. The petition asks the agency to publicly post all labels, labeling, and instructions
Drugs
New York Attorney General Letitia James and a bipartisan coalition of 47 other attorneys general have secured $17.85 million from drug manufacturers Bausch and Lannett to resolve allegations that the companies participated in a long-running conspiracy to inflate prices and limit competition for generic drugs. The settlements are
Drugs
FDA has accepted for review an Exelixis NDA for zanzalintinib in combination with the immune checkpoint inhibitor atezolizumab for patients with previously treated metastatic colorectal cancer. The application is seeking approval for treating adult patients with metastatic colorectal cancer who have previously received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and,
Drugs
FDA has launched its new PreCheck pilot program aimed at strengthening domestic pharmaceutical manufacturing by providing earlier regulatory engagement and more predictable oversight for new facilities. FDA commissioner Marty Makary says the program is part of a broader effort to reverse decades of offshoring in pharmaceutical manufacturing and improve supply
Drugs
FDA has released a corrected version of a 12/30 Complete Response Letter issued to Corcept Therapeutics, indicating that the agency had repeatedly warned the company against submitting its NDA seeking approval of relacorilant for treating hypertension associated with endogenous Cushing’s syndrome. FDA said that during the pre-submission
Drugs
Ultragenyx Pharmaceutical has resubmitted a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilippo syndrome Type A, a rare and fatal pediatric neurodegenerative disorder. Sanfilippo syndrome type A is described as a rare inherited lysosomal storage disorder caused by mutations in the SGSH gene,
Drugs
Elevar Therapeutics has submitted an NDA for lirafugratinib as a second-line treatment for patients with cholangiocarcinoma whose tumors harbor FGFR2 fusions or rearrangements. Cholangiocarcinoma (bile duct cancer) is a rare malignancy, whose treatment options are limited, particularly after first-line therapy. The NDA is supported by clinical data from
Drugs
Sen. Rick Scott (R-FL) has introduced legislation that would require prescription drug labels in the U.S. to disclose where drugs and their active pharmaceutical ingredients are manufactured, aiming to increase transparency in a supply chain that relies heavily on overseas production. The bill, the Consumer Labeling for Enhanced
Devices
On 2/2, FDA is discontinuing the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspections using the process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850). FDA will also no longer use Inspection of Medical Device
Devices
Grail has submitted the final module of its PMA for the company’s multi-cancer early detection blood test. The Galleri test, which was designated a Breakthrough Device by FDA in 2018, is designed to detect cancer signals and predict their tissue of origin from a single blood draw. It
Drugs
FDA has granted Biogen a breakthrough therapy designation for its experimental antibody litifilimab for treating cutaneous lupus erythematosus (CLE), a chronic autoimmune skin disease for which there are no approved targeted therapies. The designation was based on the totality of data generated to date for litifilimab, including results from the