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
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
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PTC Therapeutics has withdrawn its NDA resubmission for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy, following feedback from FDA indicating the application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
Drugs
A new opinion piece argues that the Trump Administration should urge FDA make a major shift in how it classifies prescription drugs by moving more medications to over-the-counter status. Writing in The Hill, Jeffrey A. Singer, a general surgeon and senior fellow at the Cato Institute, contends that
Drugs
FDA is supporting renewed scrutiny of direct-to-consumer (DTC) television advertising as CDER Office of Prescription Drug Promotion (OPDP) is stepping up enforcement activity based on recent letters to industry. OPDP has issued seven untitled letters so far in 2026 to companies, including Janssen, Sobi, Novo Nordisk, and argenx,
Drugs
Public Citizen is petitioning HHS to authorize generic competition for Novo Nordisk and Lilly’s GLP-1 weight-loss drugs. A Public Citizen statement says that generic forms of Novo Nordisk’s Wegovy, Ozempic, and Rybelsus (all semaglutide), and Lilly’s Mounjaro and Zepbound (all tirzepatide) are expected to begin
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
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
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
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
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
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