Drugs
At the 1/6 meeting of the PDUFA 8 CMC Subgroup, industry representatives explained their counterproposal to FDA’s facility lifecycle proposal. The meeting minutes indicate that industry proposed a timeline for communications associated with the form FDA-483 that is issued after a pre-approval inspection. The minutes say
Drugs
Telehealth firm Hims and Hers Health is offering compounded GLP-1 weight loss pills for $49 per month for new customers and $99 per month thereafter as part of a five-month plan, some $100 per month under the lowest price charged by innovator firm Novo Nordisk for its Wegovy
Drugs
FDA has updated the safety labeling for the widely used chemotherapy drugs capecitabine (Genentech’s Xeloda) and fluorouracil (multiple manufacturers) to strengthen warnings about the risk of serious and potentially fatal toxicities in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Capecitabine and fluorouracil are cornerstone chemotherapies used across a wide range
Drugs
An 8/4-8/12/2025 FDA inspection at the Cohance Lifesciences drug manufacturing facility in Uppal Mandal, Medchal-Malkajgiri, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/30 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained
Drugs
Responding to an FDA request for information on increasing access to nonprescription drugs, Pharmaceutical Research and Manufacturers of America (PhRMA) says that while it is aligned with the goal of increasing access to nonprescription drugs, Rx to over-the-counter (OTC) switch decisions “must remain rooted in scientific analysis of
Drugs
Senior officials in the Trump administration intervened last year to prevent FDA from placing a promising new psychedelic treatment for severe depression on a priority fast-track review list, according to multiple media reports. The treatment, developed by Compass Pathways and derived from psilocybin — the psychedelic compound found in so-
Drugs
President Trump has signed a government spending bill that officially reinstates FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program, reviving a key incentive for rare childhood disease drug development that had lapsed more than a year ago. The provision, part of the Consolidated Appropriations Act of 2026 signed
Drugs
Amgen is pushing back against an FDA request asking it to voluntarily withdraw its vasculitis drug Tavneos (avacopan) from the U.S. market due to concerns related to clinical trial adjudication and liver safety. In an Amgen notice to healthcare providers, the company says it has no plans to withdraw
Drugs
FDA has issued AstraZeneca a complete response letter declining to approve its BLA for a subcutaneous formulation of Saphnelo (anifrolumab) for treating adult patients with systemic lupus erythematosus (SLE). AstraZeneca says it has submitted the additional information requested by FDA and is continuing to work with the agency to advance
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,
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
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
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
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