Drugs
In a first-time decision, a Florida federal court has ruled that a citizen petition denial can turn an FDA Warning Letter into final agency action that can be challenged in court. Attorney Peter Dickos (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog that the case
Drugs
A new academic paper is urging FDA to proceed cautiously as it moves to phase out animal testing in drug development, warning that an overly rapid transition to newer technologies could create safety and effectiveness risks. The article, published in the journal Trends in Biotechnology, examines FDA’s recent commitment
Drugs
A 2/11 Washington Legal Foundation legal backgrounder argues that FDA would face steep statutory hurdles if it attempts to dramatically expand disclosure requirements in direct-to-consumer (DTC) pharmaceutical advertising, contending that such a move would likely fail in court under the Supreme Court’s 2024 decision in Loper
Drugs
FDA has approved labeling changes for six hormone replacement therapy (HRT) drugs to remove Boxed Warning statements relating to cardiovascular disease, breast cancer, and probable dementia. An agency media statement quotes HHS secretary Robert F. Kennedy Jr. as saying the move “reflects our commitment to follow the science wherever it
Drugs
A new article in the New England Journal of Medicine is warning that recent federal court rulings are transforming FDA-required drug labels into powerful weapons in patent litigation — a shift the authors say could chill generic competition and keep drug prices high. In a Perspective published 2/7, legal
Biologics
CBER is facing mounting scrutiny after its top official, director Vinay Prasad, overruled career staff and refused the review of Moderna’s application for a new mRNA flu vaccine — a move that insiders, industry executives and analysts say reflects broader disruption inside the Center. Now, we are learning that earlier
Drugs
FDA has released a 29-page form FDA-483 with 11 observations from a 1/27-2/6 inspection at the Eugia Pharma Specialties sterile drug product manufacturing facility in Sangareddy, Telangana, India. The inspection observations were: * failure to establish and follow written procedures designed to prevent microbiological contamination of
Biologics
FDA has granted Krystal Biotech a Regenerative Medicine Advanced Therapy (RMAT) designation for KB707, an inhalable gene therapy being investigated for treating advanced or metastatic non-small cell lung cancer (NSCLC). KB707 is described as a redosable herpes simplex type 1 virus-based immunotherapy that is designed to deliver genes
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab), as well as the fixed-dose combination pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), in combination with paclitaxel, with or without bevacizumab, for certain patients with platinum-resistant ovarian cancers. The approval covers adults with platinum-resistant epithelial ovarian, fallopian tube, or primary
Biologics
FDA has cited AGC Biologics for deficiencies in laboratory data controls and inventory management at its Bothell, WA, drug substance manufacturing site, according to a just-released Form FDA-483. FDA investigators inspected the facility 4/2025 and cited inadequate review of laboratory data associated with in-process and final
Drugs
FDA has accepted for review a Biofrontera supplemental NDA seeking to expand the label of its photodynamic therapy drug Ameluz (aminolevulinic acid hydrochloride) to include treatment of superficial basal cell carcinoma, a common form of skin cancer. Ameluz is currently approved in the U.S. for treating actinic keratosis, a
Drugs
FDA has released a draft guidance entitled “Certification Process for Designated Medical Gases.” The document explains how the agency administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs). Specifically, it discusses what products qualify as DMGs, who must submit a certification request, what information
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a Janssen Biotech direct-to-consumer TV ad for its ulcerative colitis drug Tremfya (guselkumab) injection, for subcutaneous or intravenous use, is false or misleading. A 2/6 Notice of Violation takes issue with the ad’s claims that about one
Devices
FDA has approved Novocure’s Optune Pax for use in combination with gemcitabine and nab-paclitaxel for adults with locally advanced pancreatic cancer, marking the first new FDA-approved treatment for this setting in nearly three decades. The approval is based on data from the Phase 3 PANOVA-3 trial,
Biologics
CBER director Vinay Prasad reportedly overruled the Center’s career reviewers in deciding to issue Moderna a refusal-to-file letter (see earlier story) for its BLA for an mRNA influenza vaccine, a move that is highly unusual because these procedural decisions are typically handled by review staff, not Center
Drugs
Some Republican senators left a closed-door briefing by FDA commissioner Marty Makary on the agency’s review of the abortion drug mifepristone convinced that FDA is not taking the review seriously and Congress needs to act to ban the drug. Politico quotes Sen. Josh Hawley (R-MO) as complaining
Devices
A detailed report published by the Reuters news service says FDA is receiving an increasing number of complaints about patient injuries during surgeries involving medical devices that use artificial intelligence (AI). Much of the report (paywall) discusses the Acclarent TruDI navigation system that is used to show doctors where their
Drugs
FDA has approved changes to the isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy that it says will minimize the burden on patients, prescribers, and pharmacies while maintaining the safe use of the drug. An agency announcement says the modifications include changes listed in the 11/2023 FDA notification to isotretinoin
Drugs
FDA has issued a Warning Letter to Bio-Medical Pharmaceutical Manufacturing Corporation, citing widespread GMP violations at the company’s Houston facility, including serious deficiencies in sterile drug production, process controls, and laboratory testing. The 2/5 Warning Letter follows an FDA inspection conducted 8/25–29/2025 at the
Drugs
FDA has accepted for priority review a Takeda NDA for TAK-861 (oveporexton) as a potential first-in-class treatment for narcolepsy Type 1. Narcolepsy Type 1 is a rare, chronic neurological disorder characterized by excessive daytime sleepiness and cataplexy, resulting from loss of orexin-producing neurons. The agency has
Biologics
FDA has issued Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the company’s use of a Priority Review Voucher intended to speed the process. The letter, signed by CBER director Vinay Prasad, cited the company’s choice of comparator
Drugs
FDA has issued Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (pacritinib) because it misbrands the product and violates federal law by making misleading benefit claims and omitting key safety information. The just-posted 2/6 letter from CDER Office