Devices
FDA has approved Guardant Health’s Shield blood test for colorectal cancer (CRC) screening in adults 45 years of age and older who are at average risk for the disease. It is the first blood test to be approved by the agency as a primary screening option for CRC that
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of its Pharmacy Compounding Advisory Committee for an additional two years. The new charter will be in effect until 4/25/2026. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 23 ANDAs from multiple applicants after they notified the agency that the products are no longer being marketed and requested their withdrawal. To view the notice, click here.
Drugs
AstraZeneca says data from its Phase 3 AMPLIFY trial showed that Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia. Regarding the
Drugs
A Kaleo social media post about Auvi-Q (epinephrine injection) was cited earlier this month by FDA because it presented benefit information but failed to include any risk information. CDER’s Office of Prescription Drug Promotion (OPDP) said in a just-posted untitled letter that the social media post thus
Drugs
FDA has issued Carie Boyd Pharmaceuticals a six-observation Form FDA-483 after inspecting its Irving, TX outsourcing facility last month. Agency investigators found that the firm’s procedures designed to prevent microbiological contamination of sterile drug products were inadequate. The firm was also cited for failing to thoroughly review
Drugs
FDA has approved an Alpha Cognition NDA for ZUNVEYL (benzgalantamine) for treating mild-to-moderate Alzheimer’s disease (AD). The drug has been designed with a dual mechanism of action to eliminate drug absorption in the gastrointestinal (GI) tract, “potentially addressing certain tolerability issues with leading AD medications, combined with
Devices
FDA has granted Elixir Medical a breakthrough device designation for its novel bioadaptive implant, DynamX Sirolimus-Eluting Coronary Bioadaptor System, for use in improving coronary luminal diameter, restoring hemodynamic modulation, and reducing plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions.
Drugs
FDA has approved a Sun Pharmaceutical Industries NDA for Leqselvi (deuruxolitinib) 8 mg tablets for treating adults with severe alopecia areata, a common autoimmune disease in which hair loss is thought to occur due to the collapse of “immune privilege,” according to the company. This collapse leads to the immune
FDA Policy/General
Federal Register notice: FDA is announcing the renewal for two years of its Pulmonary-Allergy Drugs Advisory Committee. The new charter will be in effect until 5/30/2026. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA announces a 9/18 Pediatric Advisory Committee meeting that will discuss post-marketing pediatric-focused safety reviews on 41 products.
Drugs
FDA has issued a warning about adverse event reports it has received that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. “Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of
Drugs
FDA has placed a clinical hold on a vTv Therapeutics Phase 3 trial (CATT1) involving cadisegliatin and its use in improving glycemic control in Type 1 diabetes patients. Cadisegliatin is an oral, liver-selective, glucokinase activator that the company says has been well-tolerated in over 500 subjects to date
Devices
A new blog post from FDA’s Digital Health Center of Excellence (DHCoE) outlines key activities that should be taking place during the lifecycle of artificial intelligence-enabled medical devices (AI lifecycle). The post provides an AI lifecycle (AILC) concept diagram that highlights systematic methods related to data and model
Devices
FDA has cleared a bioMérieux 510(k) for its Biofire Spotfire Respiratory/Sore Throat Panel Mini. Designed for use on the company’s point-of-care Biofire Spotfire system, the panel is described as a unique multiplex polymerase chain reaction test that detects five of the most common viral and
Drugs
A January inspection of Brassica Pharma’s sterile drug manufacturing facility in Maharashtra, India resulted in a just-posted 10-observation Form FDA-483 that cited significant GMP violations. For example, agency investigators said the firm’s lab records did not include complete data derived from all tests and examinations
Drugs
FDA has granted fast-track designation for AC Immune’s ACI-35.030 (now in development with Janssen as JNJ-2056) for Alzheimer’s disease. A company statement says the drug targets the pathologic form of the Tau protein, phosphorylated Tau. The Phase 2b ReTain clinical trial is recruiting participants
Drugs
FDA says Aurobindo Pharma recalled 7/18 one lot of its Healthy Living OTC Migraine Relief (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) due to a missing manufacturer label. The agency announcement says the company began shipping the affected batch to customers nationwide in January. Some bottles
FDA Policy/General
FDA has published a Veterinary International Conference on Harmonization guidance, Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2), that recommends acceptable amounts of residual solvents in pharmaceuticals for the safety of the target animal and for the safety of residues in products derived from
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled ‘‘Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.” The document is intended to provide sponsors and other interested parties with considerations when proposing to use electronic
Devices
Medtronic’s Xomed unit has recalled (Class 1) its neuromonitoring device, NIM Vital Nerve Monitoring system, due to the potential for false negative responses. A recall notice says the company notified consignees on 06/24/2024 that Medtronic had developed software version 1.5.4 to address the issue and
Biologics
FDA has published a guidance, Recommendations for Investigational and Licensed Covid-19 Convalescent Plasma, with recommendations to blood establishments for submitting a BLA for the manufacture of Covid-19 convalescent plasma for transfusion intended to treat patients with immunosuppressive disease or receiving either outpatient or inpatient immunosuppressive treatment. The document