Drugs Safety AlertMHRA Warns of Rare Botulism Risk with Botulinum Toxin Products MHRA Warns of Rare Botulism Risk with Botulinum Toxin Products Read Post »
Drugs Safety AlertJAMA Explores Evidence Behind HHS Proposed Testosterone Label Revisions JAMA Explores Evidence Behind HHS Proposed Testosterone Label Revisions Read Post »
Drugs Safety AlertEMA PRAC Adds Meningioma Warning for Desogestrel Contraceptives EMA PRAC Adds Meningioma Warning for Desogestrel Contraceptives Read Post »
Drugs Safety AlertInvivyd Plans Full FDA Approval for COVID-19 as PEMGARDA EUA Faces 2027 Exp... Invivyd Plans Full FDA Approval for COVID-19 as PEMGARDA EUA Faces 2027 Exp... Read Post »
Drugs Safety AlertPRAC Finds Inconsistent Evidence on Paternal Valproate Risk in Children PRAC Finds Inconsistent Evidence on Paternal Valproate Risk in Children Read Post »
Drugs Safety AlertFDA Updates Alli Label to Warn of Rare Risk of Acute Kidney Injury and Kidn... FDA Updates Alli Label to Warn of Rare Risk of Acute Kidney Injury and Kidn... Read Post »
Drugs Safety AlertTakeda’s ADZYNMA Gets FDA Boxed Warning After Fatal Antibody Case Takeda’s ADZYNMA Gets FDA Boxed Warning After Fatal Antibody Case Read Post »
Drugs Safety AlertMHRA Reinforces Safety Advice for Men Taking Finasteride and Dutasteride MHRA Reinforces Safety Advice for Men Taking Finasteride and Dutasteride Read Post »
Drugs Safety AlertMHRA Sets 5-Day Limit on OTC Nasal Decongestant Sprays MHRA Sets 5-Day Limit on OTC Nasal Decongestant Sprays Read Post »
Drugs Safety AlertFDA Requires Extensive Postmarketing Safety Data for Foundayo FDA Requires Extensive Postmarketing Safety Data for Foundayo Read Post »
Drugs Safety AlertOntozry Gets EMA Liver Safety Warning Ontozry Gets EMA Liver Safety Warning Read Post »
Drugs Safety AlertMifepristone Lawsuits Paused as Court Waits for FDA Safety Review Mifepristone Lawsuits Paused as Court Waits for FDA Safety Review Read Post »
Drugs Safety AlertFDA Flags Fatal Liver Injury, Including VBDS, with Tavneos (avacopan) FDA Flags Fatal Liver Injury, Including VBDS, with Tavneos (avacopan) Read Post »
Drugs Safety AlertAardvark Halts ARD-101 and ARD-201 Studies After QRS Signal in Safety Study Aardvark Halts ARD-101 and ARD-201 Studies After QRS Signal in Safety Study Read Post »
Drugs Safety AlertSeizure Risk Tied to Vitamin B6 Deficiency Prompts FDA Label Changes for Pa... Seizure Risk Tied to Vitamin B6 Deficiency Prompts FDA Label Changes for Pa... Read Post »
Drugs Safety AlertEisai Pulls Tazverik in Japan After Global Safety Review Eisai Pulls Tazverik in Japan After Global Safety Review Read Post »
Drugs Safety AlertSCFE Cases Prompt BioMarin to Halt Select VOXZOGO Trials in Rare Growth Dis... SCFE Cases Prompt BioMarin to Halt Select VOXZOGO Trials in Rare Growth Dis... Read Post »
Drugs Safety AlertLilly Warns Compounded Tirzepatide Mixed with B12 May Pose Risks Lilly Warns Compounded Tirzepatide Mixed with B12 May Pose Risks Read Post »
Drugs Safety Alert Health TidingsFDA Rolls Out AEMS Safety Dashboard, Saving $120M FDA Rolls Out AEMS Safety Dashboard, Saving $120M Read Post »
Drugs Safety AlertFDA Issues Warning Letter to Novo Nordisk Over Pharmacovigilance Deficienci... FDA Issues Warning Letter to Novo Nordisk Over Pharmacovigilance Deficienci... Read Post »
Drugs Safety AlertIpsen Withdraws Tazverik After SYMPHONY-1 Trial Flags Secondary Blood Cance... Ipsen Withdraws Tazverik After SYMPHONY-1 Trial Flags Secondary Blood Cance... Read Post »
Drugs Safety AlertKyowa Kirin Discontinues All Rocatinlimab Trials Over Emerging Malignancy R... Kyowa Kirin Discontinues All Rocatinlimab Trials Over Emerging Malignancy R... Read Post »
Drugs Safety AlertFDA Halts New Enrollment in MacroGenics’ Lorigerlimab Trial Over Safe... FDA Halts New Enrollment in MacroGenics’ Lorigerlimab Trial Over Safe... Read Post »
Drugs Safety AlertNew GBS Safety Information Added to GSK’s SHINGRIX Label New GBS Safety Information Added to GSK’s SHINGRIX Label Read Post »
Drugs Safety AlertValneva’s IXCHIQ Gets UK Safety Restrictions for Older Adults Valneva’s IXCHIQ Gets UK Safety Restrictions for Older Adults Read Post »
Drugs Safety AlertFDA Approves Genzyme’s Thymoglobulin® and Gamida Cell’s Omisirge L... FDA Approves Genzyme’s Thymoglobulin® and Gamida Cell’s Omisirge L... Read Post »
Drugs Safety AlertLevamisole to be Withdrawn from EU Market Over Leukoencephalopathy Risk Levamisole to be Withdrawn from EU Market Over Leukoencephalopathy Risk Read Post »
Drugs Safety AlertWhat’s New in the FDA’s iPLEDGE REMS Update for Isotretinoin What’s New in the FDA’s iPLEDGE REMS Update for Isotretinoin Read Post »
Drugs Safety AlertFDA Removes Boxed Warning from Menopausal Hormone Therapy Labels FDA Removes Boxed Warning from Menopausal Hormone Therapy Labels Read Post »
Drugs Safety AlertNIH Stops Low-Dose Rivaroxaban Arm in CAPTIVA Trial Over Safety Concerns NIH Stops Low-Dose Rivaroxaban Arm in CAPTIVA Trial Over Safety Concerns Read Post »
Clinical Trials Drugs Safety AlertChugai’s NXT007 Shows Promising Safety During Emicizumab Transition in Ha... Chugai’s NXT007 Shows Promising Safety During Emicizumab Transition in Ha... Read Post »
Drugs Safety AlertFDA Revises Capecitabine and 5-FU Labels to Address DPD Deficiency Risk FDA Revises Capecitabine and 5-FU Labels to Address DPD Deficiency Risk Read Post »
Drugs Safety AlertFDA Halts REGENXBIO’s RGX-111 and RGX-121 After CNS Tumor Case FDA Halts REGENXBIO’s RGX-111 and RGX-121 After CNS Tumor Case Read Post »
Drugs Safety AlertFDA Lifts Clinical Hold on Intellia’s MAGNITUDE-2 Phase 3 Trial of Nex-z ... FDA Lifts Clinical Hold on Intellia’s MAGNITUDE-2 Phase 3 Trial of Nex-z ... Read Post »
Drugs Safety AlertOrganon’s NEXPLANON Now Approved for Up to Five Years of Contraception wi... Organon’s NEXPLANON Now Approved for Up to Five Years of Contraception wi... Read Post »
Drugs Safety Alert Health TidingsFDA Issues Warning Letter to Telangana’s Palamur Biosciences Over GLP Ris... FDA Issues Warning Letter to Telangana’s Palamur Biosciences Over GLP Ris... Read Post »
Drugs Safety AlertFDA Reaffirms No Link Between GLP-1 Drugs and Suicidal Ideation; Supports L... FDA Reaffirms No Link Between GLP-1 Drugs and Suicidal Ideation; Supports L... Read Post »
Drugs Safety AlertFDA CBER Flags Rare Febrile Seizure Risk Linked to Influenza Vaccines FDA CBER Flags Rare Febrile Seizure Risk Linked to Influenza Vaccines Read Post »
Drugs Safety Alert ResearchNimesulide’s Rise and Reckoning in India: Ending with a Nationwide Ban on... Nimesulide’s Rise and Reckoning in India: Ending with a Nationwide Ban on... Read Post »
Drugs Safety AlertFDA Adds New Safety Warning to ALTUVIIIO Label FDA Adds New Safety Warning to ALTUVIIIO Label Read Post »
Drugs Safety Alert ResearchFDA Says PFAS Safety in Cosmetics Remains Uncertain Due to Data Gaps FDA Says PFAS Safety in Cosmetics Remains Uncertain Due to Data Gaps Read Post »
Drugs Safety Alert ResearchPreliminary Safety Update: Pfizer Notifies Hemophilia Community of Death in... Preliminary Safety Update: Pfizer Notifies Hemophilia Community of Death in... Read Post »
Drugs Safety Alert ResearchJAMA Study Analysing 20 Years of U.S. Data Links GLP-1 Drugs With Persisten... JAMA Study Analysing 20 Years of U.S. Data Links GLP-1 Drugs With Persisten... Read Post »
Drugs Safety Alert ResearchFDA Safety Update: Andexxa Risks Outweigh Benefits After Postmarketing Thro... FDA Safety Update: Andexxa Risks Outweigh Benefits After Postmarketing Thro... Read Post »
Drugs Safety Alert ResearchWHO Review Shows Strong Evidence That Vaccines Are Not Linked to Autism WHO Review Shows Strong Evidence That Vaccines Are Not Linked to Autism Read Post »
Drugs Safety Alert ResearchFDA Alerts on Fake Ozempic in Legitimate US Supply: Novo Nordisk Guidance A... FDA Alerts on Fake Ozempic in Legitimate US Supply: Novo Nordisk Guidance A... Read Post »
Drugs Safety Alert ResearchFDA Seizes 73,000 Illegal 7-OH Opioid Products worth $1M in Missouri: Major... FDA Seizes 73,000 Illegal 7-OH Opioid Products worth $1M in Missouri: Major... Read Post »
Drugs Safety Alert ResearchFDA Final Guidance on QTc Information in Human Prescription Drug and Biolog... FDA Final Guidance on QTc Information in Human Prescription Drug and Biolog... Read Post »
Drugs Safety Alert ResearchAustralia’s TGA Updates Safety Warnings for GLP-1 Receptor Agonists a... Australia’s TGA Updates Safety Warnings for GLP-1 Receptor Agonists a... Read Post »
Drugs Safety Alert ResearchAbbott Initiates Medical Device Correction for Freestyle Libre 3 Sensors in... Abbott Initiates Medical Device Correction for Freestyle Libre 3 Sensors in... Read Post »
