Drugs
The latest iteration of the CDER Guidance Agenda projects that the Center will issue 85 new or revised guidances in CY 2026. The guidances are in these 14 categories: * administrative/procedural (8 guidances) * artificial intelligence (2) * biosimilars (6) * biostatistics/clinical/medical (2) * clinical/medical (9) * clinical pharmacology (5) * compounding (8)
Drugs
FDA has approved Merck's Lipfendra (enlicitide) 20 mg tablets as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including patients with heterozygous familial hypercholesterolemia (HeFH), marking the first approval of an oral proprotein convertase subtilisin/kexin type 9
Drugs
FDA has released the form FDA-483 with 13 observations from a 4/13-4/24 inspection at the Zhejiang Hushai Pharmaceutical Co. drug manufacturing facility in Zhejiang, China. The inspection observations were: * failure to make written records of investigations into unexplained discrepancies or the failure of a batch or
Drugs
The American Society of Health System Pharmacists (ASHP) says the 227 active drug shortages in the second quarter of 2026 represent an increase for the third consecutive quarter but remain significantly lower than the all-time high of 323 shortages in the first quarter of 2024. The ASHP report says
Drugs
Rep. Diana DeGette (D-CO) took FDA to task recently, winning assurances from the agency that several policy announcements issued during former commissioner Marty Makary's tenure — including articles published in medical journals and media interviews — are not intended to be recognized as official agency guidance. During a 4/
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
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
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
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
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:
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
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&
Drugs
FDA has issued final guidance establishing recommendations for formal meetings between the agency and sponsors or requestors developing over-the-counter (OTC) monograph drugs, providing a standardized framework for obtaining regulatory advice throughout product development. The guidance, “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph