Drugs
FDA is soliciting public comment on a proposed study of healthcare providers’ perceived barriers to sufficient patient enrollment in pregnancy exposure registries. A Federal Register notice says human pregnancy safety data are collected post-approval to ensure that pregnancy information in product labeling is accurately communicated to healthcare providers (HCPs)
Drugs
FDA says it is working with manufacturers to increase supplies of estradiol transdermal patches after reports that some patients are having difficulty finding their usual products at pharmacies. In a 9/3 update, the agency says it is working with all six manufacturers of FDA-approved estradiol transdermal patches to
Drugs
FDA has approved Ionis Pharmaceuticals’ Zanvastro (zilganersen) injection for treating Alexander disease in pediatric and adult patients — the first approved treatment for the disease and the first therapy to directly target the protein buildup that causes it. The rare, progressive neurological disorder is caused by mutations in the gene that
Drugs
FDA has granted AstraZenenca an accelerated approval for Etcamah (camizestrant), an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. The approval applies to
Drugs
AbbVie is reporting “positive topline results” from the Phase 3 CERVINO study evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, versus standard available therapies (SAT) in patients with triple-class exposed (proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody) relapsed/refractory multiple myeloma (RRMM). CERVINO met
Drugs
The consulting firm RMS says its analysis of over 300 complete response letters (CRLs) posted by FDA since 2025 shows that the most effective strategy for coping with CRL risk is prevention. Writing in the Real Economy blog, RMS says, “Companies that identify and resolve potential regulatory, quality, and manufacturing
Drugs
FDA is seeking public input and comments on its efforts to advance the development of botanical drug products (BDPs). A Federal Register notice to be published on 9/4 says the agency wants to “better understand stakeholders’ perspectives on the state of BDP development in the U.S., challenges encountered,
Drugs
Writing in an FDA Voices column, four senior agency executives describe ways in which FDA is strengthening its oversight of good clinical practice (GCP) as the ethical and scientific foundation for clinical investigations of all regulated products. The column was written by CDER acting director Michael Davis, CBER acting director
Drugs
The American Society of Gene & Cell Therapy (ASOCT) says an FDA draft guidance on leveraging prior knowledge in developing human gene therapy products incorporating genome editing would have greater value if it applied more broadly across cell and gene therapy modalities and provided greater clarity about how knowledge accumulated
Drugs
CBER has published a Standard Operating Policy and Procedure (SOPP), Complying with Requirements Under the Pediatric Research Equity Act (PREA) & Best Pharmaceuticals for Children Act (BPCA), as a resource to ensure that sponsors/applicants and CBER staff follow the required procedures and timeframes under the two laws. The SOPP
Drugs
A Friends of Cancer Research (Friends) white paper proposes a fit-for-purpose approach to support administered activity escalation and dosage optimization in radiotherapeutic therapy (RPT) development. Friends says its approach is based on these core principles: * use escalation to generate RPT-specific evidence; * anchor decisions to the totality of
Drugs
CDRH has issued an alert on AVID Medical convenience kits based on a letter the company sent to customers recommending that certain kits be corrected prior to continued use by removing components affected by the earlier Huons Co., Ltd. recall. The Center says users should not use sodium chloride ampules
Drugs
FDA has ordered a Boxed Warning for American Regent’s Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophosphatemia, a potentially serious condition in which phosphate levels in the blood become abnormally low. The warning recommends monitoring blood phosphate levels in patients considered at risk for the condition, as
Drugs
FDA has released a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage. The document is intended to assist sponsors in their design and analysis of studies that assess the influence of impaired hepatic function (hepatic impairment (HI)) on the pharmacokinetics
Drugs
A 3/2-3/6 FDA inspection at the Fresenius Medical Care North America drug manufacturing facility in Ogden, UT, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/25 Warning Letter says the two specific violations were: * failure to thoroughly investigate any unexplained
Drugs
Novartis and Bristol Myers Squibb have each paused some studies of CAR T candidates while adverse events are evaluated. BioSpace reports Novartis suspended multiple studies of its rapcabtagene autoleucel (rap-cel) after three patients who received the therapy suffered fatal cases of immune effector cell-associated hemophagocytic syndrome. Meanwhile, the
Drugs
A 2/19-2/27 FDA inspection at the Reliance Life Sciences Private Limited drug manufacturing facility in Navi Mumbai, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/18 Warning Letter says the specific violations were: * failure to ensure that laboratory
Drugs
Clear rules are needed for when FDA decides to publicly release complete response letters (CRL), according to a new analysis published in the Journal of Law and the Biosciences. The CRL postings, which were launched under former FDA commissioner Marty Makary as part of a broader “radical transparency” effort, are
Drugs
FDA and the International Coalition of Medicines Regulatory Authorities (ICMRA) have completed an assessment of a new biologics testing approach that could reduce use of horseshoe crab blood while continuing to ensure product quality. The assessment is part of the ICMRA Collaborative Assessment Pilot, which brings participating international regulators together
Drugs
The Washington, DC Court of Appeals appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after missing its FDA-mandated approval deadline. In Norwich Pharmaceuticals Inc. v. Kennedy, the court ruled that a first generic applicant can avoid forfeiting its exclusivity for missing
Drugs
Karyopharm Therapeutics has submitted a supplemental NDA seeking accelerated approval for Xpovio (selinexor) in combination with ruxolitinib for patients with myelofibrosis. Karyopharm has requested a priority review, which, if granted, could result in a six-month review. The sNDA is based, in part, on data from the Phase 3 SENTRY
Drugs
IDEAYA Biosciences says it had a successful FDA Type C meeting to determine the Phase 3 registrational trial design for IDE849, a delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) and its use in extensive stage small cell lung cancer (ES-SCLC). IDEAYA is planning