Drugs
FDA has told KalVista Pharmaceuticals that it will not meet a 6/17 user fee review action target data for its NDA for sebetralstat, indicated for treating hereditary angioedema (HAE). The agency said the goal date would not be met due to heavy workload and limited resources, according to the
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) as the first anti‑PD‑1 therapy that can be given both before and after surgery for adults with resectable, locally advanced head and neck squamous‑cell carcinoma whose tumors express PD‑L1. The approval allows the drug to be used as a
Drugs
FDA has placed a clinical hold on a Rein Therapeutics Phase 2 (RENEW) trial of LTI-03 to request additional non-clinical information. The company says LTI-03 is a novel, multi-pathway Caveolin-1-related peptide being developed for treating patients with idiopathic pulmonary fibrosis (IPF). “Importantly, to date
Drugs
FDA has released a final guidance entitled “ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submissions.” The document describes and provides recommendations on the content, timing, and assessment of a PFC for a priority ANDA. It also provides information regarding FDA’s assessment process for a PFC.
FDA Policy/General
Senators Bernie Sanders (I-VT) and Angus King (I-ME) have introduced legislation that would ban direct-to-consumer drug advertising across television, radio, print, digital platforms, and social media. Their End Prescription Drug Ads Now Act aligns with HHS secretary Robert F. Kennedy Jr., who advocated for such a
Biologics
FDA has scheduled a 7/17 meeting of its Oncologic Drugs Advisory Committee to review and vote on a GSK BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior line of therapy; and
Devices
FDA says the Medtronic 5/2025 recall of specific Newport HT70 and HT70 Plus ventilators and certain related Newport service parts is Class 1. An agency notice says the company was advising customers to discontinue clinical use of the affected devices. Investigation into customer complaints identified two separate capacitors on
Biologics
Questions are being raised about some of the eight people HHS secretary Robert F. Kennedy, Jr., has appointed to the CDC Advisory Committee on Immunization Practices (ACIP). The appointments were made after Kennedy “retired” all 17 of the current members, the Associated Press reports, raising concerns among public health experts
Drugs
A recent FDA pre-license inspection of Capricor Therapeutics’ San Diego manufacturing facility for Deramiocel, the company’s lead cell therapy candidate with a BLA under agency review for its use in treating Duchenne Muscular Dystrophy (DMD) concluded with a Form 483 containing several observations, the company says, adding that
Drugs
FDA has approved a UroGen Pharma NDA for Zusduri (mitomycin intravesical solution) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Approval was based on data from the ENVISION trial (NCT05243550) that evaluated patients’ complete response (CR) at three months and duration of response (DoR)
Devices
FDA has cleared a Viz.ai 510(k) for the Viz Subdural Plus, which the company describes as the “first and only comprehensive solution for quantifying the size of collections like subdural hemorrhages (SDH) in the subdural space on non-contrast computed tomography (NCCT) images." The device is designed
FDA Policy/General
Rutgers Health researchers say they have determined that GlaxoSmithKline’s antiseizure drug Lamictal (lamotrigine) is safe in older adults with epilepsy, contrary to an FDA safety warning. An online university post says that in 2020 FDA put a safety warning on the lamotrigine label based on reports the drug could
FDA Policy/General
In a 6/11 email to FDA staff, commissioner Martin Makary said he wants to consolidate many agency operations to streamline its work. The Regulatory Affairs Professionals Society (RAPS) said it obtained a copy of the email for its report. The email indicated Makary wants to consolidate operations such as
Drugs
FDA has granted Sumitomo Pharma America a fast track designation for nuvisertib (TP-3654) and its use in treating patients with intermediate or high-risk myelofibrosis (MF). The company describes nuvisertib as an oral, highly selective inhibitor of PIM1 kinase, which demonstrated clinical activity, including symptom and spleen responses correlating
FDA Policy/General
Dozens of current and former CDC employees rallied outside the agency’s Atlanta headquarters yesterday over Trump Administration-inspired chaos affecting the health agency. The protest came one day after 342 current and recently fired NIH employees posted a letter criticizing the administration’s politicization of research and the elimination
Drugs
A 1/7-1/10 FDA inspection at the Amish Origins Management drug manufacturing facility in Worland, WY, found significant violations of current good manufacturing practice (CGMP) regulations in its manufacturing of unapproved and misbranded external analgesic and sunscreen products. A 5/28 Warning Letter says specific CGMP violations were:
Drugs
FDA has published reports on the real-world evidence submissions to CBER and CDER in FY 2024, as required under the PDUFA VII reauthorization. The summary report (includes links to the CBER and CDER statistics pages) says the reporting intends to describe submissions to FDA containing real-world data to
Drugs
FDA says the CDER Center for Clinical Trial Innovation’s Bayesian Statistical Analysis demonstration project supports the goal of increasing the use and understanding of Bayesian statistical methods in simple clinical trial settings across sponsors, CDER clinical reviewers, and CDER statisticians. An online post says the demonstration provides a structured
Drugs
The Federal Trade Commission and the Department of Justice Antitrust Division are scheduling three live-streamed listening sessions on aspects of the push to lower the cost of prescription drugs for Americans. “The listening sessions will focus on improving the affordability of pharmaceuticals by increasing generic and biosimilar availability and
Drugs
FDA has approved an AbbVie expanded label for Mavyret (glecaprevir/pibrentasvir) to include treating adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, the oral pangenotypic direct-acting antiviral therapy is the first
Drugs
FDA has approved a Nuvation Bio NDA for Ibtrozi (taletrectinib), a kinase inhibitor for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. Approval was based on data from two multicenter, single-arm, open-label clinical trials, TRUST-I (NCT04395677) and TRUST-II (NCT04919811), an FDA
Drugs
FDA commissioner Marty Makary says the agency will improve the communication channels between reviewers and companies to help speed innovation and medical product development. Makary shared this upcoming improvement in a just-posted podcast that discussed some of the feedback he and other officials are receiving as part of an