Drugs
FDA has issued an amended Warning Letter to Sanofi, replacing the 12/16/2024 letter addressing significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs) found in a 6/12-7/9/2024 inspection at the firm’s Genzyme Corp. subsidiary in Framingham, MA. The
Drugs
FDA has approved a Johnson & Johnson supplemental NDA for Spravato (esketamine) nasal spray for monotherapy use in treating adults with major depressive disorder who have had an inadequate response to at least two oral antidepressants. Previously, Spravato was approved for combination use with an oral antidepressant for treating adults
Drugs
FDA has published a guidance, Bioanalytical Method Validation for Biomarkers, to help sponsors of INDs and applicants of NDAs, BLAs, sNDAs, sBLAs, and ANDAs to validate bioanalytical methods used to evaluate biomarker concentrations. The document says it can also inform the development of bioanalytical methods used to analyze biomarker concentrations
Drugs
FDA has released the form FDA-483 issued following a 12/2-12/20/2024 inspection at SCA Pharmaceuticals, a Windsor, CT, outsourcing facility. The seven inspection observations were: * failure to thoroughly review any unexplained discrepancy whether or not the batch had already been distributed; * failure to establish written procedures
Drugs
One of dozens of actions president Donald Trump took after being inaugurated 1/20 orders all government departments and agencies like FDA to end work-from-home arrangements and head back to the office “as soon as practicable.” Many FDA employees continue to work full-time from home or in
Biologics
FDA has accepted for priority review a Replimune Group BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. The agency has set a user fee review action target date of 7/22. The BLA is supported by data from the IGNYTE trial demonstrating that one-
Drugs
FDA has lifted a clinical hold on an Amylyx Pharmaceuticals Phase 1 clinical trial of AMX0114, an investigational antisense oligonucleotide targeting calpain-2 for treating amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease). The company plans to initiate the Phase 1 LUMINA clinical trial in Canada early
FDA Policy/General
Federal Register notice: FDA is amending its regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during 10/2024, 11/2024, and 12/2024. The regulations are also being amended to improve accuracy and readability. To view the notice, click here.
Drugs
FDA has approved Amgen’s Lumakras (sotorasib) for use with its Vectibix (panitumumab) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The agency also approved Qiagen’s therascreen KRAS RGQ
Drugs
A new CDER guidance agenda shows that the Center is committing to issuing 11 drug quality guidance documents in 2025. Under GMP pharmaceutical quality, the agenda says the following four documents will be published: * Approaches to Meeting CGMP Requirements for Distributed Manufacturing * Laboratory Testing of Drugs Held in Interstate Commerce:
Drugs
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Drugs
An FDA update says all new neonatal incubators currently supplied in the U.S. do not show “concerning levels of airborne chemicals and therefore do not need to be run for a week before clinical use.” The agency raised concern about such devices 2/2023 and issued an alert stating
Drugs
FDA has granted AstraZeneca traditional approval for Calquence (acalabrutinib) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. Traditional approval was also granted for acalabrutinib’s use as a single agent for adults with previously treated MCL.
Devices
In 2024, CDRH granted marketing authorization to 120 novel devices, which was four less than the previous year’s record-setting 124 devices, according to the Center’s just-released 2024 annual report. The Center also continues to see increasing interest from developers to bring their novel technologies to market
FDA Policy/General
Federal Register notice: FDA is seeking public comments on the use of cannabis-derived products (CDPs) in animals. The agency says it wants to learn more about general trends associated with CDPs, including information about: usage trends (e.g., product selection, indications, etc.), quality standards, benefits of use, potential drug
FDA Policy/General
Voicing the belief that FDA commissioner-nominee Martin Makary can have a successful tenure at the agency, commissioner Robert Califf, former commissioners Scott Gottlieb and Mark McClellan, and former acting commissioner Janet Woodcock used their time on a panel at the 2025 Summit sponsored by the University of California San
Drugs
Boehringer Ingelheim says its Phase 3 CONNEX clinical trial program evaluating iclepertin in cognitive impairment in adults with schizophrenia did not meet primary and key secondary endpoints. “Overall, no statistically significant effects on cognition or functioning were observed in patients treated with iclepertin versus placebo at six months,” it says,
Devices
Medline Industries has recalled (Class 1) its Medline Fluid Delivery Set with Drip Chamber because the devices were incorrectly assembled with a white macro drip chamber instead of the required gray micro drip chamber. “The macro drip chamber delivers three times more fluid per drop than the micro drip chamber,
Devices
FDA says it is aware that Fresenius Kabi USA has contacted affected healthcare providers recommending updates to certain software versions of the Ivenix Infusion System. An agency Early Alert says the recommended updates are related to a potentially high-risk device issue. The notice lists anomalies reported by the company
Drugs
An FDA alert is warning healthcare professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, FL, and Endo USA, in Malvern, PA. The alert says healthcare professionals have confused these products with FDA-approved injectable epinephrine products for intravenous use. “BPI Labs and Endo
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Recommendations To Reduce the Risk of Transfusion — Transmitted Malaria.” The document recommends selectively testing blood donations from donors at risk for malaria using an FDA-licensed donor screening nucleic acid test (NAT) for Plasmodium species, which cause malaria. To
Drugs
FDA has issued Atara Biotherapeutics a complete response letter on its BLA for Ebvallo (tabelecleucel), a monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease, who have received at least one prior therapy including an anti-CD20