Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On August 5, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (brand…
Horse Doping Seller Sentenced to 42 Months in Manhattan Federal Court
Department of JusticeSouthern District of New York FOR IMMEDIATE RELEASEThursday, September 8, 2022 Lisa Giannelli Sentenced to 42 Months in Prison Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant LISA GIANNELLI, received a sentence of 42 months in prison today for her role in an approximately 20-year scheme…
Abbott MitraClip Device: Potential for Clip Lock Malfunctions – Letter to Health Care Providers
September 8, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott. On September 8, 2022, Abbott issued an Urgent Medical Device Correction to inform health care providers about the issue. An increased rate of reports of clip lock…
FDA D.I.S.C.O. Burst Edition: Tabrecta (capmatinib) for metastatic non-small cell lung cancer and Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-mutant non-small cell lung cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on two recent FDA cancer drug approvals. On August 10, 2022, the FDA granted regular approval to…
Philips Respironics Alerts Customers Worldwide of Updated Instructions and Labeling of Specific Sleep Therapy Masks That Contain Magnetic Headgear Clips Due to Potential Risk of Serious Injury
Summary Company Announcement Date: September 06, 2022 FDA Publish Date: September 06, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description potential risk of serious injury Company Name: Royal Philips’ subsidiary Philips Respironics Brand Name: Brand Name(s) Product Description: Product Description Certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or…
Former Paramedic Pleads Guilty to Fentanyl Tampering
Department of JusticeDistrict of Massachusetts FOR IMMEDIATE RELEASETuesday, September 6, 2022 BOSTON – A former Massachusetts emergency medical technician (EMT) paramedic has pleaded guilty to tampering with liquid fentanyl vials at the ambulance company at which she worked. Candice Mangan, 43, of Medford, pleaded guilty on Aug. 30, 2022 in federal court in Boston to one…
Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
Date Issued: September 6, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern….
Fluorouracil and Pet Safety
Image CaptionCourtesy Photo For many households, pets are our best friends. For some people they are also indispensable service animals. Many show their affection by licking us. Others like to chew on things—your furniture, your shoes, your purse – anything that’s within reach. This includes medicated cream containers you apply to your skin that are…
Albuquerque Supplement Retailer Sentenced to Three Years’ Probation for Performance Enhancing Drugs
Department of JusticeDistrict of New Mexico FOR IMMEDIATE RELEASEThursday, September 1, 2022 PEDs Were Banned by U.S. and World Anti-Doping Agencies ALBUQUERQUE, N.M. – Alexander M.M. Uballez, United States Attorney for the District of New Mexico, announced that Tanya Puccini was sentenced on Aug. 30 to three years of probation for introduction and delivery of misbranded…
South Florida Federal Judge Orders Prison Time for Former Pharmatech CEO
Department of JusticeSouthern District of FLorida FOR IMMEDIATE RELEASEThursday, September 1, 2022 Miami, Florida – A former owner and CEO of a Broward County drug manufacturing company who lied to the FDA and allowed contaminated products to make their way to pediatric hospitals was sentenced yesterday to 37 months in federal prison. Raidel Figueroa co-owned Pharmatech,…