The Knowledge Shelf

MHRA

Looking to our future: reflections on the strategic choices ahead for the MHRA
ByDossier Experts September 16, 2025

As part of developing its new five-year strategy, the MHRA is publishing a series of blogs on the challenges and opportunities ahead. In the first instalment, Chief Executive Lawrence Tallon reflects on the changing healthcare landscape, the regulator’s role, and the priorities shaping the agency’s future direction.

Read More Looking to our future: reflections on the strategic choices ahead for the MHRA
MHRA

Vorasidenib approved to treat patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
ByDossier Experts September 16, 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 16th September 2025, approved the medicine vorasidenib (Voranigo).

Read More Vorasidenib approved to treat patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
US FDA

BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets
ByDossier Experts September 15, 2025

FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performanc

Read More BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets
US FDA

Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes
ByDossier Experts September 12, 2025

DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.

Read More Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes
US FDA

Influenza (Flu) Antiviral Drugs and Related Information
ByDossier Experts September 12, 2025

Flu is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Your best defense is vaccination, which provides important protection from flu and its potential complications.

Read More Influenza (Flu) Antiviral Drugs and Related Information
US FDA

Update on Alert: Defibrillation Lead Issue from Boston Scientific
ByDossier Experts September 12, 2025

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.

Read More Update on Alert: Defibrillation Lead Issue from Boston Scientific
US FDA

Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure
ByDossier Experts September 12, 2025

Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia.

Read More Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure
US FDA

From Our Perspective
ByDossier Experts September 12, 2025

Insights from CDER leadership and experts on public health actions

Read More From Our Perspective
US FDA

Olympia Pharmaceuticals. Orlando, FL. 483 issued 08/08/2025
ByDossier Experts September 12, 2025

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Olympia Pharmaceuticals. Orlando, FL. 483 issued 08/08/2025
FEI Number 3009724085
Firm Name Olympia Pharmaceuticals
Record Type 483
State FL
Establishment Type Outsourcing Facili

Read More Olympia Pharmaceuticals. Orlando, FL. 483 issued 08/08/2025
US FDA

Completed PDUFA VI Deliverables
ByDossier Experts September 12, 2025

Completed PDUFA VI Deliverables

Read More Completed PDUFA VI Deliverables
MHRA

Apply for manufacturer or wholesaler of medicines licences
ByDossier Experts September 12, 2025

How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.

Read More Apply for manufacturer or wholesaler of medicines licences
US FDA

Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement – FDA Safety Communication
ByDossier Experts September 11, 2025

Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.

Read More Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement – FDA Safety Communication