Drugs

Date Listed Date of Letter Name of Company Issuing Department Topic 11/05/2024 06/03/2024 Top Health Manufacturing, LLC Division of Human and Animal Food Operations West IV CGMP/Dietary Supplement/Adulterated 11/05/2024 10/10/2024 Analytical Food Laboratories, Inc. Center for Drug Evaluation and Research […]

Date Released Date of Issue Business Name Office of Issue Topic 10/01/2024 08/13/2024 NRS Enterprises, Inc. d/b/a Sunflour Bakery Division of Human and Animal Food Operations West V CGMP/Food/Prepared, Packed or Held Under Unsanitary Conditions/Adulterated 10/01/2024 09/20/2024 Shake Hemp Center

Date Posted Date Issued Organization Issuing Division Category 09/03/2024 08/19/2024 Kaylaan LLC Division of Pharmaceutical Quality Operations I CGMP/Adulterated Pharmaceuticals 09/03/2024 08/16/2024 EBCREATE Store Center for Tobacco Products Tobacco Act/Misbranded 09/03/2024 08/01/2024 Dasada Group LLC Division of Southwest Imports FSVP

Issued On Dated Company Department Focus Area 08/06/2024 07/23/2024 Omega Tech Labs LLC Pharmaceutical Quality Operations Dept. IV CGMP/Finished Drugs/Adulterated/Unapproved 08/06/2024 08/01/2024 Guangzhou Baiyunshan Pharmaceutical CDER CGMP/Finished Drugs/Adulterated 08/06/2024 07/17/2024 Velocity Pharma LLC CDER CGMP/Finished Drugs/Adulterated 08/06/2024 07/16/2024 La Parcela

ICICI Prudential Life Insurance recently unveiled ICICI Pru Wish, a groundbreaking health insurance product focused on women-specific serious ailments and surgeries. Created in collaboration with the Reinsurance Group of America (RGA), this insurance scheme targets the distinct health issues faced

DigiNerve, an innovative educational technology initiative by Jaypee Brothers Medical Publishers, is setting a new standard in orthopaedic medical instruction through the launch of its all-encompassing MS orthopaedics program. This course, crafted under the mentorship of top orthopaedic surgeons and

Introduction to Lasix ONYU’s Tentative Approval Gerresheimer, a pioneering provider of systems and solutions across pharmaceutical, biotech, and cosmetic sectors, announces the US Food and Drug Administration’s (FDA) provisional approval of SQ Innovation’s Lasix ONYU. This combination product, designed for

GSK plc has revealed that the European Medicines Agency (EMA) has awarded Priority Medicines (PRIME) status to GSK5764227 (GSK’227), a B7-H3-aimed antibody-drug conjugate (ADC) undergoing trials for patients with recurrent extensive-stage small-cell lung cancer (ES-SCLC). The PRIME Designation facilitates the

Innovent Biologics, a prominent biopharmaceutical company, and Eli Lilly and Company have jointly announced a Distribution and Promotion Agreement focused on introducing Lilly’s reversible BTK inhibitor, Jaypirca, to Mainland China. This partnership entails Innovent taking charge of importing, marketing, distributing,

Bavarian Nordic A/S, a worldwide leader in vaccine innovation aimed at improving health and saving lives, has struck a licensing and production deal with Serum Institute of India Pvt. Ltd. (SII) to manufacture its MVA-BN mpox vaccine. This collaboration involves