The Knowledge Shelf

US FDA

FarmaKeio Outsourcing LLC. Southlake, TX. 483 issued 09/05/2025
ByDossier Experts December 2, 2025

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) FarmaKeio Outsourcing LLC. Southlake, TX. 483 issued 09/05/2025
FEI Number 3014982757
Firm Name FarmaKeio Outsourcing LLC
Record Type 483
State TX
Establishment Type Outsourcing

Read More FarmaKeio Outsourcing LLC. Southlake, TX. 483 issued 09/05/2025
MHRA

MHRA approves tisotumab vedotin for the treatment of cervical cancer
ByDossier Experts December 2, 2025

As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used

Read More MHRA approves tisotumab vedotin for the treatment of cervical cancer
MHRA

Promotional material: Vaccine safety – patient factsheet
ByDossier Experts December 2, 2025

Patient factsheet to provide information on vaccines and vaccine safety.

Read More Promotional material: Vaccine safety – patient factsheet
US FDA

Monoclonal Antibodies: Streamlined Nonclinical Safety Studies
ByDossier Experts December 2, 2025

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies.”

Read More Monoclonal Antibodies: Streamlined Nonclinical Safety Studies
MHRA

Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs)
ByDossier Experts December 2, 2025

An initiative to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.

Read More Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs)
MHRA

Field Safety Notices: 24 to 28 November 2025
ByDossier Experts December 2, 2025

List of Field Safety Notices from 24 to 28 November 2025.

Read More Field Safety Notices: 24 to 28 November 2025
US FDA

Recall Alert: Glycar SA Removes Pericardial Patch
ByDossier Experts December 1, 2025

Certain SJM Pericardial Patches from Glycar SA may not meet the required tensile strength specification

Read More Recall Alert: Glycar SA Removes Pericardial Patch
US FDA

What You Should Know about Eye Drops
ByDossier Experts December 1, 2025

Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Eye drops are available by prescription or sold as OTCs.

Read More What You Should Know about Eye Drops
US FDA

Patient-Focused Drug Development
ByDossier Experts December 1, 2025

The OCE PFDD program fosters collaboration between FDA centers and external stakeholders involved in patient outcomes research in cancer populations.

Read More Patient-Focused Drug Development
US FDA

FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease
ByDossier Experts December 1, 2025

The FDA granted supplemental approval to Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.

Read More FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease
US FDA

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
ByDossier Experts December 1, 2025

FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar to its reference product Novolog (insulin aspart), to improve glycemic control in adults and children with diabetes mellitus.

Read More FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
US FDA

Central Admixture Pharmacy Services Inc. Phoenix, AZ. 483 issued 09/05/2025
ByDossier Experts December 1, 2025

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) Central Admixture Pharmacy Services Inc. Phoenix, AZ. 483 issued 09/05/2025
FEI Number 3014307835
Firm Name Central Admixture Pharmacy Services Inc
Record Type 483
State AZ
Estab

Read More Central Admixture Pharmacy Services Inc. Phoenix, AZ. 483 issued 09/05/2025

The Knowledge Shelf

FarmaKeio Outsourcing LLC. Southlake, TX. 483 issued 09/05/2025

MHRA approves tisotumab vedotin for the treatment of cervical cancer

Promotional material: Vaccine safety – patient factsheet

Monoclonal Antibodies: Streamlined Nonclinical Safety Studies

Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs)

Field Safety Notices: 24 to 28 November 2025

Recall Alert: Glycar SA Removes Pericardial Patch

What You Should Know about Eye Drops

Patient-Focused Drug Development

FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes

Central Admixture Pharmacy Services Inc. Phoenix, AZ. 483 issued 09/05/2025

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