Drugs
FDA has accepted for review an Axsome Therapeutics NDA for AXS-12 (reboxetine) for the treatment of cataplexy in patients with narcolepsy. The agency has set a review action target date of 5/1/2027. If approved, AXS-12 would become a new treatment option for cataplexy, a hallmark symptom
Devices
A 2/23-2/24 FDA inspection at Nihon Kohden Digital Health Solutions in Irvine, CA, determined that the firm manufactures the Next Generation NetKonnect software device, described as a patient physiological monitor device with an arrhythmia detector and alarm. A just-released 6/12 Warning Letter says the device
Drugs
Witnesses appearing before a House Energy and Commerce Health Subcommittee hearing are urging lawmakers to modernize the nation's clinical trial system, strengthen FDA’s scientific capacity, and increase federal investment in biomedical research, warning that China is rapidly eroding the leadership the U.S. has held in early-
Drugs
Republican and Democrat leaders on the House Energy and Commerce Health Subcommittee revealed differing views over whether the Trump administration's policies are strengthening or undermining the nation's drug development enterprise. The opposing views emerged during opening statements at a hearing examining FDA's role in
Drugs
FDA acting commissioner Kyle Diamantas is commenting on the traditional agency public health pillars that are being rearticulated “in a way that reflects the scientific, technological, and geopolitical reality shaping this new era of innovation as well as the future of public health.” Writing in an FDA Voices online column,
Drugs
FDA has issued a voluntary action indicated (VAI) close-out letter to HLB and its U.S. subsidiary Elevar Therapeutics for the current good manufacturing practice inspection (CGMB) that led to the agency’s most recent complete response letter for rivoceranib plus camrelizumab as a first-line treatment for unresectable
Biologics
HHS aide Stefanie Spear, a close associate of HHS secretary Robert F. Kennedy Jr. for many years, has been asking FDA to provide access to its Sentinel and BEST surveillance system data to help the HHS staff conduct studies, including into rates of autism and other conditions among vaccinated versus
EIRs/483s
FDA has granted Roche a priority review for its supplemental BLA seeking approval for Gazyva (obinutuzumab) for treating adults with primary membranous nephropathy (pMN), potentially positioning the anti-CD20 antibody as the first FDA-approved therapy for the rare autoimmune kidney disease. The agency is expected to complete its review
Drugs
Neurelis, the NDA holder for Valtoco (diazepam) nasal spray, indicated for the acute treatment of intermittent stereotypic episodes of frequent seizure activity in patients with epilepsy aged 6 years and older, that was later expanded through an sNDA to aged 2 and older, is asking FDA to ensure that applicants
Drugs
Rep. Frank Pallone (D-NJ), the ranking member on the House Energy and Commerce Committee, has asked the Government Accountability Office (GAO) to analyze the impact of the FDA reduction-in-force (RIF) efforts through the so-called Department of Government Efficiency (DOGE) or other means on the agency’s
FDA Policy/General
A group of prominent academic and public health experts is urging FDA to embrace greater transparency, scientific independence and regulatory consistency, arguing that public confidence in the agency has eroded amid concerns over political interference and shifting regulatory standards. In a commentary published Tuesday in Fortune, Jeffrey Sonnenfeld of the
Drugs
FDA has converted the accelerated approval of Eli Lilly's Retevmo (selpercatinib) into a traditional approval for treating adult and pediatric patients with locally advanced or metastatic RET fusion-positive solid tumors. The agency announced Tuesday that selpercatinib is now fully approved for adults and children ages two years
Drugs
A 12/9-12/19/2025 FDA inspection at the International Medication Systems drug manufacturing facility in South El Monte, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/2 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained
Devices
A 1/5-1/12 FDA inspection at ZIIP, Inc. in Pleasant Hill, CA, determined that the firm manufactures the ZIIP HALO device and the HALO 2.0, ZIIP DOT, and ZIIP Gels. A just-released 5/22 Warning Letter says all of the devices other than the original ZIIP
Drugs
Biogen executives sought to reassure investors Tuesday that its experimental anti-tau Alzheimer's disease therapy remains a promising late-stage candidate despite a sharp market selloff following detailed Phase 2 study results that raised questions about the drug's dose-response profile. During an investor call held
Drugs
FDA has finalized updated guidance for industry outlining current recommendations for demonstrating bioequivalence (BE) of generic topical dermatologic corticosteroids, replacing a policy that had been in place since 1995. The guidance, “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence,” provides ANDA sponsors with expanded recommendations on designing and conducting pharmacodynamic vasoconstrictor studies
Drugs
The House Energy and Commerce Subcommittee on Health will hold a hearing 7/15 examining how FDA can help strengthen U.S. leadership in biomedical innovation amid growing concerns that early-stage drug development is increasingly shifting overseas. The hearing, titled "Maintaining America's Leadership in Biomedical Innovation:
FDA Policy/General
The prescription drug advertising industry is increasingly concerned that FDA is planning rulemaking that could effectively eliminate branded direct-to-consumer (DTC) television advertising by removing a longstanding regulatory provision governing risk disclosures. Earlier this month, HHS outlined plans to release a proposed rule in December that would require broadcast
Drugs
Ascelia Pharma is pushing back against FDA's recent public release of a Complete Response Letter (CRL) for its MRI contrast agent Orviglance, arguing that the agency's concerns center on the image-reading process used in its pivotal Phase 3 study rather than deficiencies in the study
EIRs/483s
GSK says its PD-1 inhibitor Jemperli (dostarlimab) achieved the primary endpoint in a registrational Phase 2 trial in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer, paving the way for regulatory submissions that could establish the drug as the first immunotherapy to
Drugs
FDA has issued a guidance detailing its current recommendations for developing psychedelic drug products, providing sponsors with the agency's most comprehensive roadmap to date for addressing manufacturing, nonclinical testing, clinical trial design, abuse potential, and long-term safety considerations. The guidance acknowledges the growing interest in psychedelic therapies
Drugs
FDA has approved a new subcutaneous dosing regimen for Eisai's Alzheimer's disease therapy Leqembi (lecanemab-irmb), allowing patients to begin treatment at home rather than first receiving intravenous infusions at a healthcare facility. The approval marks the first time an amyloid beta-directed antibody for Alzheimer&