Drugs
Eight House Democrats are asking FDA to address estrogen patch shortages for menopause treatment. The seven — Reps. Debbie Dingell (D-MI), Deborah Ross (D-NC), Eleanor Holmes Norton (D-DC), Andrea Salinas (D-OR), Jesus Garcia (D-IL), Yvette Clark (D-NY), Rashida Tlaib (D-MI), and Emily Randall (D-
Biologics
FDA has approved a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older. The approval follows a June Vaccines and Related Biological Products Advisory Committee meeting that supported the vaccine’s approval. "The FDA approval of mFLUSIVA, our fourth
Drugs
FDA appears to be signaling that increased regulatory oversight might be on the horizon for unapproved animal-derived thyroid medications, which are used by an estimated 1.5 million Americans to treat hypothyroidism. The agency says it plans to issue new draft guidance outlining its enforcement priorities for such products.
Drugs
A 59% surge in FDA drug Warning Letters in 2025 over 2024 is not the result of isolated mistakes but rather “is the predictable outcome of a structural problem the industry has tolerated for too long.” That’s the view of Krieger Scientific founder and CEO Joseph Morwald, as expressed
Devices
AdvaMed says it strongly supports the draft MDUFA 6 agreement. Speaking at an FDA public hearing, association executive vice president for digital and diagnostics technologies Zach Rothstein said the commitment “builds on what is working, makes practical improvements where they are needed, and prepares the program for the technologies FDA
Biologics
FDA has granted accelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, in combination with Bristol Myers Squibb's Opdivo (nivolumab), for treating adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)
Devices
The International Medical Device Regulators Forum (IMDRF), of which FDA is a founding member, has published a final document outlining global principles for Predetermined Change Control Plans (PCCPs), a regulatory approach intended to streamline updates to medical device software while maintaining safety and regulatory oversight. The “Essential Principles and Content
Drugs
FDA has accepted for review a Merck supplemental BLA for Enflonsia (clesrovimab-cfor) to expand its indication to include preventing respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children under age two years at increased risk for severe RSV disease through their second RSV season. The agency has
Drugs
Two senior U.S. senators are seeking answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs. In an 8/5 letter to FDA acting commissioner Kyle Diamantas, Sens. Rick Scott (R-FL) and Kirsten Gillibrand (D-NY) requested a briefing by 9/4 on
Drugs
FDA is continuing to outline its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing that the changes are needed to prevent drug development from shifting overseas and to accelerate first-in-human clinical trials in the U.S. In an 8/5
FDA Policy/General
FDA has finalized a guidance, Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern, that outlines a quantitative risk assessment framework for the agency to evaluate whether and to what degree a given antimicrobial drug used in food-producing
Drugs
FDA has issued a Request for Information (RFI) seeking feedback from industry, academia, healthcare providers, patient groups, and other interested parties on identifying critical community needs and establishing mechanisms for continuous engagement, supporting collaborative demonstration projects or research on innovative approaches aimed at addressing high-priority areas through the application
Drugs
Minutes of a Type C meeting between FDA and Tonix Pharmaceuticals show the agency and company aligned on the protocol for an adaptive Phase 2 study of Tonix’ TNX-4800 (human anti-outer-surface protein A monoclonal antibody) to prevent Lyme disease in adults. A company statement says the adaptive
Drugs
FDA has cited multiple manufacturing and quality system deficiencies at a Zydus Lifesciences Limited sterile manufacturing facility in Ahmedabad, Gujarat, India, including concerns related to aseptic processing controls, environmental monitoring, airflow studies and data review procedures, according to a just -posted FDA Form 483 issued following a 4/25-5/
Drugs
FDA has approved Takeda’s Orzeyful (oveporexton) tablets to treat narcolepsy type 1 in adults. An agency statement says Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder, addressing the full range of symptoms that define the condition. It is the first drug to work
Drugs
Fresenius Kabi is recalling (Class 1) one lot of Simplist (morphine sulfate injection USP) 2 mg/1 mL prefilled syringes after discovering a labeling mix-up that could result in patients receiving hydromorphone. According to Fresenius Kabi, a MicroVault labeled as morphine sulfate injection 2 mg/1 mL may contain
Drugs
An FDA review of records requested from Thomas Brunner GmbH, a Baden-Württemberg, Germany, over-the-counter drug manufacturer, identified significant violations in the firm’s manufacturing of misbranded, unapproved drugs. A 7/24 Warning Letter lists these violations of the Federal Food, Drug, and Cosmetic Act: * failure to have,
Drugs
Jazz Pharma says it will seek FDA approval to remove Zepzelca’s (lurbinectedin) second-line metastatic small cell lung cancer (SCLC) indication based on data from the company’s LAGOON trial. In June, Jazz reported (see earlier story) that the confirmatory study failed to meet its primary endpoint of overall
Biologics
FDA has accepted for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked masseter muscle prominence (MMP) associated with masseter muscle activity in adults. “MMP can contribute to the appearance of a wider or more square lower
Devices
FDA has issued an early alert warning healthcare providers not to use certain Becton Dickinson (BD) intraosseous vascular access needle sets after the company identified a manufacturing defect that has been linked to delays in establishing emergency vascular access, including reports of four deaths and 45 serious injuries. The alert
Drugs
Liebel-Flarsheim is recalling (Class 1) one lot of its Optiray Imaging Bulk Package 350 radiographic contrast agent after identifying particulate contamination that could pose serious health risks if injected. A recall notice says the affected lot contains particulate matter identified as polyethylene and other plastic materials, stainless steel and
Drugs
The International Council for Harmonization (ICH) M8: Electronic Common Technical Document (eCTD) Implementation Working Group has issued updated support materials for eCTD v4.0. An ICH statement (contains links to the support materials) says the updates cover the implementation guide package, the controlled vocabulary package, and the Q&A