Dr. Amina Farouk MD, MSc Pharmacovigilance
Global Safety and Pharmacovigilance Analyst
Dr. Amina Farouk analyzes safety updates, risk mitigation plans, and post-market surveillance trends. She has 15 years of pharmacovigilance experience supporting multinational product teams across oncology, immunology, and cardiovascular portfolios.
Articles by Dr. Amina Farouk

Oncolytics Biotech Pelareorep Shows Durable Responses in RAS-Mutant Colorectal Cancer Trial
Oncolytics Biotech reports sustained clinical benefit with pelareorep immunotherapy in second-line RAS-mutant MSS colorectal cancer patients.

Purdue Pharma Shutdown: $7.4B Deal Ends OxyContin Maker's Era
Purdue Pharma, the manufacturer of OxyContin, is ceasing operations as part of a $7.4 billion settlement to address its role in the opioid crisis. This landmark agreement aims to resolve thousands of lawsuits and redirect company assets towards addiction treatment and prevention.

ANVISA Regulatory Changes: Key Impact on Foreign Drug Manufacturers in Brazil
ANVISA's recent regulatory changes significantly affect foreign drug manufacturers in Brazil, influencing drug approvals and market strategies for key treatments.

Biosimilars Growth in Brazil: Market Potential Post-ANVISA Regulatory Updates
This article delves into the market potential for biosimilars in Brazil following recent ANVISA regulatory updates, highlighting Infliximab's role in treating autoimmune conditions.

Plozasiran TGA Approval in Australia for FCS Patients
Arrowhead Pharmaceuticals has announced the Therapeutic Goods Administration (TGA) approval of REDEMPLO® (plozasiran) in Australia for patients with Familial Chylomicronemia Syndrome (FCS). This landmark decision broadens global access to a crucial treatment for this rare genetic disorder.

FDA Advisory Committee Recommends AstraZeneca's TRUQAP for PTEN-Deficient Metastatic Prostate Cancer
FDA's Oncologic Drugs Advisory Committee recognizes favorable benefit-risk profile for TRUQAP (capivasertib) in PTEN-deficient metastatic prostate cancer treatment.

Alkeus Pharmaceuticals Presents Gildeuretinol Data for Stargardt Disease at ARVO 2026
Alkeus Pharmaceuticals announces clinical data presentation for investigational oral gildeuretinol treating Stargardt disease at ARVO 2026 meeting.

COFEPRIS Generic Drug Approval: Market Impact & Competitive Shift 2025
This article analyzes the implications of COFEPRIS's generic drug approval for hypertension treatments, highlighting market dynamics and competitive shifts expected in 2025.

FDA Accelerated Approval Oncology: 2026 Review of Evolving Pathways
This article reviews the FDA's Accelerated Approval pathways for oncology drugs, focusing on advancements and the impact on treatments like Keytruda.

Saudi Arabian pharmaceutical market: SFDA's accelerated drug approvals impact
The SFDA's expedited drug approval process is reshaping the Saudi Arabian pharmaceutical landscape, enhancing access to critical medications such as insulin for diabetes management.

Rise of Biosimilars in US: FDA Approval Trends & Market Impact
The article delves into the growing presence of biosimilars in the US market, focusing on FDA approval trends and their implications for drug pricing and patient access.

SFDA Accelerated Approval Oncology: Expanding Access with Anktiva in Saudi Arabia
The SFDA's accelerated approval of Anktiva enhances treatment options for oncology patients in Saudi Arabia, improving access to innovative therapies.

Boehringer Ingelheim's Survodutide Achieves 16.6% Weight Loss in Phase 2 Obesity Trial, Outperforming Current Market Leaders
Survodutide delivered 39.2 lb average weight loss in 76-week trial, potentially superior to Wegovy and Zepbound in competitive obesity market.

Cytokinetics MYQORZO (Aficamten) Takes Center Stage at European Society of Cardiology Heart Failure 2026 Congress
Cytokinetics presents nine studies on MYQORZO (aficamten) at ESC Heart Failure 2026, including late-breaking science on the newly approved oHCM treatment.

EU Pharmaceutical Legislation Reform: Impact on Orphan Drug Development & Market Exclusivity
This article examines how recent EU pharmaceutical legislation reforms affect orphan drug development and market exclusivity, shaping the future of rare disease therapies.

EMA Conditional Approvals CAR-T: What You Need to Know on B-Cell Lymphomas
Explore the latest on EMA Conditional Approvals for CAR-T therapies targeting B-Cell Lymphomas, including treatment efficacy and patient outcomes.

FDA Biosimilar Approval Pathway: Key Regulatory Changes & Market Impact 2026
This article delves into the FDA's regulatory changes for biosimilars, their implications for drug pricing, and the future landscape of patient care in 2026.

PMDA SAKIGAKE Designation: Review of Approved Drugs & Impact in Japan
This article reviews the PMDA SAKIGAKE Designation, highlighting approved drugs such as XYZ for cancer treatment and its significant impact on Japan's pharmaceutical landscape.

EMA Conditional Approval Pathway: Case Study on Repotrectinib Oncology Drug
This article delves into the EMA Conditional Approval Pathway, highlighting the case study of Repotrectinib for treating ROS1-positive oncology patients.

NMPA Approval Trends 2024: Accelerated Approvals & Key Therapies in China
Discover the latest NMPA approval trends for 2024, focusing on accelerated approvals and significant therapies such as XYZ for cancer in China.