Drugs
FDA has approved Janssen Biotech’s Tecvayli (teclistamab) in combination with Darzalex Faspro (daratumumab hyaluronidase-fihj) for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. The approval also converts teclistamab’s previous
Drugs
FDA has granted Hemab Therapeutics a breakthrough therapy designation for sutacimig, an experimental therapy being developed to prevent bleeding episodes in patients with Glanzmann thrombasthenia. Hemab said sutacimig could become the first prophylactic therapy specifically designed to prevent bleeding in people with Glanzmann thrombasthenia, a rare inherited platelet disorder that
Drugs
Rep. Jake Auchincloss (D-MA) is escalating his criticism of FDA’s new voucher program that offers select drugmakers sharply shortened review timelines, arguing the program undermines scientific standards and the agency’s credibility. In an interview with U.S. News & World Report, Auchincloss, a member of the House
Drugs
FDA is reviewing a petition to add sweeping new Warnings to commonly prescribed antidepressants, a process now complicated by the involvement of the agency’s top drug official, who is attempting to hire the physician behind the request. Acting CDER director Tracy Beth Hoeg is reportedly working to recruit Adam
Drugs
FDA has just posted the form FDA-483 with six observations from a 5/25-6/2/2023 inspection at the Fujian Genohope Biotech sterile drug manufacturing facility in Putian, Fujian, China. The specific inspection observations were: * failure to follow written procedures for the receipt, identification, storage, handling, sampling, testing,
Drugs
FDA has denied an 8/17/2025 petition filed by Age Reversal Unity seeking a regulatory framework for conducting expedited clinical trials of aging-related therapeutics within a nine-month timeframe. The agency’s denial letter says, “FDA does believe that issuing such a one-size-fits-all framework is
Drugs
FDA has denied a 6/12/2025 BioMarin petition asking for agency actions relating to C-type natriuretic peptide analogs. The denial letter says BioMarin asked that FDA: * refrain from approving any C-type natriuretic peptide (CNP) analog as a treatment for achondroplasia in any pediatric patients until 11/19/
Drugs
FDA has granted Vanda Pharmaceuticals a long-sought formal evidentiary public hearing to review the agency’s proposal to refuse approval of a supplemental NDA for Hetlioz (tasimelteon) and its use for treating jet lag disorder. A 3/2 letter from FDA’s Office of the Commissioner confirmed the hearing
Drugs
FDA has cited Chinese active pharmaceutical ingredient manufacturer Hubei JXBio Pharmaceutical Co for multiple deficiencies in its handling of deviations and out-of-specification results following a March 2025 inspection, according to a just-posted FDA Form 483. The inspection of Hubei JXBio identified shortcomings in the company’s documentation,
Drugs
FDA is seeking public input on whether to revise a longstanding series of manufacturing guidance documents that govern how drugmakers manage postapproval changes to their products. Comments are being sought on updating the agency’s Scale-Up and Postapproval Changes (SUPAC) guidances, which outline a risk-based framework for evaluating
Drugs
FDA has posted a new draft guidance entitled “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.” The document is intended to assist applicants requesting new clinical investigation exclusivity (“3-year exclusivity”) for a new drug application (NDA) or NDA supplement and provides other information about
Drugs
FDA has issued 30 Warning Letters to telehealth companies for making false or misleading claims about compounded GLP-1 medications on their Web sites. “Compounded drugs can be important for overcoming shortages or meeting unique patient needs—but compounders should not try to compound drugs in a way that circumvents
Drugs
FDA has published the International Council for Harmonization’s M14 guidance, General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies that Utilize Real-World Data for Safety Assessments of Medicines. The document covers general principles for planning, designing, analyzing, and reporting non-interventional studies that use fit-
Drugs
FDA has published the International Council for Harmonization (ICH) E2D(R1) guidance, Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports. The document says it is important to establish an internationally standardized procedure to ensure the quality of postapproval safety information and to harmonize,
Drugs
FDA has just posted the form FDA-483 issued following a 1/15-1/19/2024 inspection at the Fukuzyu Pharmaceutical Co. facility manufacturing active pharmaceutical ingredients (API) in Toyama, Japan. The inspection observations were: * failure of the firm’s quality unit to always conduct investigations for out-of-specification
Drugs
FDA has cited a Novo Nordisk direct-to-consumer advertisement for its blockbuster diabetes drug Ozempic (semaglutide), calling the ad misleading and violating federal drug promotion rules. Specifically, the 2/26 untitled letter from CDER Office of Prescription Drug Promotion (OPDP) says a promotional video titled “Ozempic vs. – Random Guy
Drugs
HHS secretary Robert F. Kennedy Jr. said last week that FDA will soon make about 14 peptides “more accessible.” Politico reports Kennedy commented on Joe Rogan’s podcast. Politico says the move will please many of Kennedy’s Make America Healthy Again followers who promote the amino acids for a
Drugs
Merck says that adding Welireg (belzutifan) to Keytruda as adjuvant therapy significantly reduced the risk of disease recurrence or death in certain patients with earlier-stage renal cell carcinoma (RCC), marking the first positive Phase 3 study of the HIF-2α inhibitor in early-stage disease. Results from the pivotal
Drugs
FDA has accepted for priority review a Takeda and Protagonist Therapeutics NDA for rusfertide, positioning the drug as a potential first-in-class treatment for adults with polycythemia vera (PV). The agency has set a user fee review action target date for the third quarter. Rusfertide is described as a
Drugs
FDA has lifted a clinical hold against Intellia Therapeutics and its MAGNITUDE Phase 3 trial of nexiguran ziclumeran (nex-z), an experimental CRISPR-based therapy for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM). The agency originally placed clinical holds on the MAGNITUDE and MAGNITUDE-2 trials in 10/2025
Drugs
FDA’s draft guidance endorsing minimal residual disease (MRD) as a potential basis for accelerated drug approvals in multiple myeloma marks a watershed moment for the field, according to leading myeloma researcher C. Ola Landgren. In an interview with Targeted Oncology, Landgren said the agency’s draft document reflects nearly
Drugs
FDA and drug industry negotiators working on the next reauthorization of the Prescription Drug User Fee Act (PDUFA) confronted lingering divisions over FDA’s “America First” proposals and the structure of hiring commitments, according to just-posted meeting minutes from a 1/29 virtual steering committee meeting. A central focus