Articles by Dr. Mei Lin
BioMarin's PALYNZIQ Receives FDA Approval for Adolescent PKU Patients 12 and Older
BioMarin announces FDA approval of PALYNZIQ for adolescents 12+ with phenylketonuria (PKU), expanding treatment options for rare genetic disorder patients.
a2 Milk Company Recalls Three Batches of a2 Platinum Infant Formula Due to Health Risk Concerns
a2 Milk Company voluntarily recalls three batches of a2 Platinum Premium USA infant formula for 0-12 months due to potential health risks to babies.
Auvelity FDA Approval: New MDD Treatment Option
The FDA has approved Auvelity, a new oral antidepressant from Axsome Therapeutics, offering a novel mechanism of action for adults with major depressive disorder (MDD). This landmark approval signifies a significant advancement in depression treatment options.
SAKIGAKE Designation Japan: Bispecific Antibodies for Leukemia Status 2026
This article delves into the SAKIGAKE Designation in Japan for bispecific antibodies, focusing on their potential to transform leukemia treatment by 2026.
Vector Science & Therapeutics Files Patent for Microneedle Catheter Platform for Cancer Drug Delivery
Vector Science & Therapeutics secures IP protection for novel microneedle catheter technology designed to deliver cancer drugs directly into tumors.
ImmunityBio Faces Securities Fraud Lawsuit Over Anktiva Off-Label Promotion After FDA Warning Letter
ImmunityBio hit with class action lawsuit after FDA determined company made false claims about Anktiva bladder cancer drug's capabilities beyond approved use.
COFEPRIS CAR-T therapies review: What You Need to Know
This article reviews COFEPRIS CAR-T therapies, focusing on their application in treating blood cancers and what patients need to know before considering treatment.
Newleos Begins Phase 1b Trial of NTX-2001 for Alcohol Use Disorder Treatment
Newleos doses first patient in Phase 1b study of NTX-2001, a TAAR1 partial agonist targeting alcohol use disorder, marking key development milestone.
EU HTA Regulation 2026: Impact on Pharma Market Access & Pricing
The EU HTA Regulation 2026 will reshape market access and pricing strategies for pharmaceuticals, significantly affecting drugs like XYZ for cancer treatment.
Adagrasib Phase 3 Trial Results: Key Insights on KRAS G12C NSCLC
The Phase 3 trial results of Adagrasib highlight its promising efficacy in treating KRAS G12C NSCLC, offering new hope for patients with this challenging cancer.
China NMPA Data Integrity: What Foreign Pharma Must Know for Approval
Understanding China NMPA data integrity is crucial for foreign pharmaceutical companies seeking approval for their drugs in the competitive Chinese market.
Radiotherapy in African Cancer Centers: Current Status & Expansion Plans 2024
This article discusses the advancements and expansion plans for radiotherapy in African cancer centers, highlighting the need for improved cancer treatment options.
ANVISA Accelerated Approval: Transforming Brazil's Pharma Market Access by 2026
ANVISA's Accelerated Approval initiative is set to revolutionize Brazil's pharmaceutical landscape, enhancing access to critical treatments like XYZ for cancer by 2026.
EU Clinical Trial Site Selection: Impact of New Qualification Requirements on Timelines
This article examines the implications of new qualification requirements on the timelines for clinical trial site selection in the EU, particularly for oncology drugs.
SFDA Expedited Review Oncology: What You Need to Know
Learn how the SFDA's expedited review process is transforming oncology drug approvals, including insights on Keytruda and its impact on cancer care.
Immunic Appoints Dr. Michael Panzara as Chief Medical Officer to Lead Vidofludimus Calcium Development
Immunic Inc. names multiple sclerosis drug development expert Dr. Michael Panzara as CMO to advance Vidofludimus Calcium through pivotal trials.
WuXi AppTec Reports 39.4% Revenue Growth in Q1 2026, Backlog Reaches RMB 59.77 Billion
WuXi AppTec delivers strong Q1 2026 results with 39.4% revenue growth and 71.7% profit increase, signaling robust pharmaceutical outsourcing demand.
Bispecific Antibodies in Hematological Malignancies: Teclistamab & Market Trends 2025
Teclistamab is revolutionizing treatment for hematological malignancies, with emerging market trends set to influence bispecific antibody therapies by 2025.
Market Analysis: FDA Approval Revnasiran and Hereditary ATTR Amyloidosis
This article analyzes the market dynamics following FDA approval of Revnasiran for hereditary ATTR amyloidosis, highlighting its significance in patient care.
PMDA Advances Japanese Pharmacopoeia and Medical Device Standards Development Through Enhanced Regulatory Science Framework
Japan's PMDA strengthens pharmaceutical and medical device standards through expanded regulatory science initiatives and Japanese Pharmacopoeia updates.