Drugs
A 5/12-5/16/2025 FDA Bioresearch Monitoring Program inspection at the clinical trial site maintained by Dr. Bertrand Cole in Portsmouth, NH, found objectionable conditions in two clinical investigations. A 2/2 Warning Letter says Cole failed to ensure that the investigation was conducted according to the investigational
Biologics
FDA has agreed to review Moderna’s seasonal influenza mRNA vaccine after previously refusing to file the BLA (see earlier story), a reversal that follows mounting scrutiny of the agency’s handling of mRNA products. The agency flip-flop followed what media reports describe as an unusual, high-level meeting
Drugs
The Sedgwick Recall Index says there were 978 medical device recalls in 2025 involving 490.23 million units. The report says that was fewer recalls but more units than in 2024 (1,059 events and 440.41 million units). The total number of recalled units in 2025 was the highest
Drugs
A newly published FDA perspective in the New England Journal of Medicine outlines a significant shift in how the agency intends to evaluate new drug applications: moving from a longstanding default expectation of two pivotal trials to one. In the article, FDA commissioner Marty Makary and CBER director Vinay Prasad
Drugs
Eli Lilly is reporting that combining its psoriasis biologic Taltz (ixekizumab) with obesity drug Zepbound (tirzepatide) led to significantly greater skin clearance and weight loss than Taltz alone in adults with moderate-to-severe plaque psoriasis and obesity or who are overweight. Topline results from the 52-week Phase 3b
Drugs
FDA has accepted and will review the Hansa Biopharma BLA for imlifidase, which has been conditionally approved as Idefirix in several other jurisdictions for the desensitization treatment of highly sensitized adult kidney transplant patients. A company statement says imlifidase is a unique IgG-cleaving enzyme that rapidly inactivates more than
Drugs
FDA commissioner Marty Makary says the agency will step up enforcement against unlawful mass compounding of GLP-1 weight-loss drugs, pursue an aggressive agenda to move more medicines over the counter, and accelerate early-stage clinical trials in the U.S. Speaking to CNBC at a policy event in
Drugs
Three Hyman, Phelps & McNamara attorneys mark Rare Disease Month by expressing their desire for a future in which regulatory flexibility is applied consistently when appropriate. Writing in their firm’s FDA Law Blog, the attorneys say that while the agency’s Rare Disease Innovation Hub aims to “enhance and
Drugs
Having operated since its Fall 2024 inception with no dedicated budget and only the director as a full-time staff member, the FDA Rare Disease Innovation Hub is poised to move forward in 2026 with $1 million in funds from CBER and CDER and a small dedicated staff. The Hub
Drugs
FDA has accepted for priority review a Bristol Myers Squibb NDA for iberdomide in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma. If approved, iberdomide would become the first therapy in a new class of medicines known as cereblon E3 ligase modulators, or CELMoD agents.
Biologics
FDA’s recent refusal to review Moderna’s application for an mRNA-based seasonal influenza vaccine has reignited concerns that vaccine policy — particularly involving mRNA technology — is becoming increasingly entangled with politics, with potentially far-reaching consequences for public health and drug development, according to a Competitive Enterprise Institute blog
FDA Policy/General
The Center for Veterinary Medicine (CVM) says promotional communications for Elanco Animal Health’s Pradalex (pradofloxacin injection) contain false or misleading claims and representations about the product’s safety and effectiveness. A just-released 1/6 Warning Letter says the promotional communications misbrand Pradalex, which CVM says is especially concerning
Drugs
A 3/31-4/8/2025 FDA inspection at the Cosmetic Manufacturers ' drug manufacturing facility in Helensvale, Queensland, Australia, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/6 Warning Letter says the specific violations were: * failure to have, for each batch of
Drugs
Compass Pathways says its investigational psilocybin therapy met the primary endpoint in a second pivotal Phase 3 trial for treatment-resistant depression, positioning the company to seek FDA approval later this year for what could become the first FDA-approved classic psychedelic therapy. The company says the Phase 3 COMP006
Devices
An FDA Early Alert says the agency is aware that Trividia Health has issued an urgent medical device correction for updated use instructions for four models of its True Metrix blood glucose monitors. The alert says the company is correcting the E-5 error code in the Messages section of
Biologics
The Senate HELP Committee has released a report with 15 recommendations for reforming FDA. The report says innovation in medical care and treatment is meaningless unless it creates products that actually help patients. “Discoveries that never leave the lab help no one,” it declares. “FDA has enormous leverage over how
Drugs
A wave of FDA enforcement letters on drug promotion activities is reshaping how pharmaceutical companies approach direct-to-consumer (DTC) television advertising, according to industry consultant Bob Ehrlich. In a 2/17 post, Ehrlich says the agency has been relying on a “totality of the evidence” standard in recent violation
Devices
As part of FDA’s recent implementation of the Quality Management System Regulation (QMSR), a new risk-based inspection model is set to change medical device oversight. The updated framework is detailed in the agency’s revised Inspection of Medical Device Manufacturers Compliance Program Manual (CP-7382.850) and applies
Drugs
PTC Therapeutics has withdrawn its NDA resubmission for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy, following feedback from FDA indicating the application was unlikely to meet the agency’s evidentiary standard for approval. The Warren, N.J.-based drugmaker said FDA informed the company during its ongoing review
Drugs
Sen. Tom Cotton (R-AR) is pressing FDA to investigate whether illegal or unregulated Chinese-sourced active pharmaceutical ingredients (APIs) have entered the U.S. supply chain and been used in compounded GLP-1 weight loss drugs. In a 2/13 letter to FDA commissioner Martin Makary, the Arkansas lawmaker
Drugs
FDA has issued Disc Medicine a complete response letter (CRL) for its experimental therapy bitopertin, indicated for treating erythropoietic protoporphyria, or EPP. The Watertown, MA-based company was seeking accelerated approval under the Commissioner’s National Priority Voucher pilot program. The letter said FDA had concluded that while mid-stage
Drugs
FDA has cited Zydus Lifesciences’ sterile drug manufacturing facility in Vadodara, India, for significant quality control and aseptic processing deficiencies following an inspection conducted in September. In a just-posted Form FDA 483, investigators documented failures to adequately investigate microbial contamination events and out-of-specification (OOS) laboratory results tied