USFDA Issues Warning Letter to Alembic Clinical Investigator Over Informed Consent Form Issues on July 21, 2026 Alembic Pharmaceuticals bioequivalence facility bioequivalence study Cautionary Warning Clinical Investigators Consent Forms Letter [Publication Type] United States Food and Drug Administration Vadodara +
Novo Nordisk and Alvotech Face Continued FDA Scrutiny at Plants Tied to Recent FDA Rejections on July 17, 2026 Alvotech Biosimilars Bloomington Indiana Cautionary Warning Letter [Publication Type] Ozempic Plainsboro New Jersey Qualitative form Reykjavik plant scrutiny United States Food and Drug Administration +
FDA drops blood pressure device enforcement against Whoop on June 25, 2026 Advice Blood Pressure Insights BPI gene Cautionary Warning enforcement enforcement action Health Letter [Publication Type] Protein Domain United States Food and Drug Administration Whooping respiration +
Medline Faces FDA Warning Over Repeat *Bacillus cereus* Contamination in Drug Products on June 04, 2026 adulteration Bacillus cereus Cautionary Warning Cyclic GMP Illinois (geographic location) Letter [Publication Type] manufacturing Medline toxic bacteria United States Food and Drug Administration Waukegan +
ImmunityBio Responds to FDA Warning on Anktiva Promotional Claims with New Protocols on April 07, 2026 Anktiva Cautionary Warning ImmunityBio Letter [Publication Type] Malignant neoplasm of urinary bladder Promotional Claims Protocols documentation United States Food and Drug Administration +
ImmunityBio Faces FDA Warning Letter Over Anktiva Promotions in TV Ad and Podcast Episode on March 24, 2026 Anktiva Cautionary Warning ImmunityBio Letter [Publication Type] podcast Promotion (action) TV ad United States Food and Drug Administration +
Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility on September 11, 2025 adulteration alpha 1-antitrypsin Cautionary Warning GMP violations Hikal Jigani Facility Letter [Publication Type] Manufacturer Metals United States Food and Drug Administration +
FDA Issues Untitled Letter to NJ Drugmaker for Misleading Cancer Drug Claims at Conference on March 05, 2025 Antineoplastic Agents booth Edenbridge Letter [Publication Type] Promotion (action) United States Food and Drug Administration +