Friday, January 16, 2026

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Granupas Marketing Halt: Implications for Tuberculosis Treatment

An unexpected decision by Eurocept International B.V. to cease the commercial distribution of Granupas (aminosalicylic acid) marks a significant turning point in therapies aimed...

EMA Prioritizes Varicella Vaccine Safety Amid Regulatory Updates

In an era where public health hinges on quick, knowledgeable responses, the European Medicines Agency (EMA) fortifies its alliance with pharmaceutical entities to champion...

Regulatory Insights: Europe’s Latest Pharmacovigilance Strategies

In the ever-evolving landscape of pharmaceutical regulation, periodic safety update single assessments (PSUSA) play a crucial role in safeguarding public health. Recently, a significant...

PRAC Assesses Safety Profile of BIMERVAX COVID-19 Vaccine

Public trust hinges on continual safety assessments of COVID-19 vaccines, like the BIMERVAX, a recombinant, adjuvanted product. The Pharmacovigilance Risk Assessment Committee (PRAC) evaluates...

FDA Cracks Down on Illegal 7-OH Products with Massive Seizure in Missouri

In an unprecedented enforcement action, the U.S. Food and Drug Administration (FDA), alongside the Department of Justice and the U.S. Marshals Service, targeted the...

Alfalfa Sprouts Recall Sparks Salmonella Concerns in Australia

Australia's alfalfa sprout consumers face a health alert following a national recall initiated by Parilla Fresh due to possible Salmonella contamination. The recall comes...

Laboratoire Aguettant Withdraws Application for Hydrocortisone Aguettant for Preterm Infants

Laboratoire Aguettant has encountered a setback in its journey to bring Hydrocortisone Aguettant to the market for the prevention of bronchopulmonary dysplasia (BPD) in...

Fasturtec Supply Shortage Resolved, Returning Stability to Hyperuricemia Treatment

The European Medicines Agency (EMA) announces a significant update: the supply shortage of Fasturtec, a critical medication for hyperuricemia, has been successfully resolved. This...

Osurnia: Key Updates and Implications for Veterinary Use

Osurnia, a veterinary medicine containing terbinafine, florfenicol, and betamethasone acetate, is authorized for use within the European Union. Known for its role in treating...

Influenza Vaccine Safety Procedures Under EU Scrutiny

Safety remains a top priority for drug monitoring agencies globally, and the European Union (EU) sits at the forefront of this vigilance. Recently, the...

EU Updates Regulatory Process for Diamorphine Safety Assessment

The European Medicines Agency (EMA) continues to prioritize pharmaceutical safety by meticulously evaluating periodic safety update reports (PSURs) for authorized medicines. This rigorous evaluation...

Sileo’s Marketing Variation Application Discontinued: Commercial Factors at Play

The withdrawal of a variation application for the veterinary medicine Sileo captured attention, signaling pivotal business decisions within the pharmaceutical landscape. Orion Corporation, which...

PRAC’s Decisions Reveal New Safety Concerns for Pharmaceuticals

The ever-evolving landscape of medication safety takes another critical turn as the Pharmacovigilance Risk Assessment Committee (PRAC) unveiled pivotal evaluations and recommendations in its...

FDA Approves Dectomax-CA1, First Drug Targeting New World Screwworm in Cattle

Addressing the urgent demand from America's agricultural community, the FDA has conditionally authorized a groundbreaking solution against New World screwworm infestations in cattle. This...

EU Assesses Drug Safety and Risk Mitigation at PRAC October Session

In an era bustling with advancements in human medicine, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) plays a crucial role in...

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