Tag: FDA approval

GC Biopharma Targets Full Utilization of Plasma Centers with FDA Approval of ABO Plasma

GC Biopharma's ABO Plasma gains FDA approval for its Laredo center, enhancing plasma sourcing and operational efficiency ahead of schedule.

Samsung Bioepis Secures U.S. Approval for Pen-Style Stelara Biosimilar, Setting a Market First

Samsung Bioepis receives FDA approval for Epyztek, the first pre-filled pen for autoimmune treatments, enhancing patient convenience.

Samsung Bioepis Taps Harrow to Take Over U.S. Ophthalmic Drug Rights from Biogen

Samsung Bioepis partners with Harrow to sell ophthalmic treatments in the U.S., transferring rights from Biogen by 2025.

J&J Aims to Treat Cancer Before It Starts Showing Symptoms

Johnson & Johnson leads in multiple myeloma treatment, pioneering early intervention for high-risk patients with a new subcutaneous formulation.

Novo Nordisk Pushes for First Oral Obesity Drug Approval

Novo Nordisk seeks FDA approval for oral Wegovy, potentially the first oral obesity treatment, amid competition with Eli Lilly.

FDA Ruling Paves Way for Pharmacy Substitution of Yuflyma for Humira

Celltrion's Yuflyma receives FDA approval for interchangeability with Humira, boosting market confidence and distribution in the U.S.

FDA Greenlights CMG’s Film-Based Schizophrenia Medication ‘Mezofy’

CMG Pharmaceutical gains FDA approval for Mezofy, a unique oral film for schizophrenia, marking a milestone for South Korean pharma.

Top News

What Did They Discuss? Inside the Unexpected Meeting Between South Korea’s...

Il Chang Kim - September 4, 2025

South Korea's National Assembly Speaker Woo Won-sik met with Kim Jong-un, raising interest in their discussions as it's the first high-level meeting since the Moon administration.

Dialysis Unit Certification Not Just a Label but a “Survival Signal”…...

March 27, 2026

Unlocking the Future of Cancer Treatment: UCI-101 CAR-NK Therapy by UCI...

April 6, 2026

Musk’s Tesla Invests Billions in Samsung, LG Energy Solution

July 31, 2025

SK hynix ADR Launch: Why Global Investors Are Betting 70 Billion...

July 9, 2026

LG Makes a Buzz with First-ever Pollinator Garden in U.S. Headquarters

April 23, 2024

President Lee Says “May New Year’s Blessings Fall On North Korea…...

January 8, 2026

Unveiling North Korea’s Choe Hyon Destroyer: What This Means for Regional...

June 25, 2026

- Our Sponsors Ad -

How China’s Solar and EV Technologies Are Reshaping Asia Amid US-Iran Conflict

President Yoon Hits Pause on Domestic Issues for Czech Republic Visit

Tired All the Time? Your Lethargy Might Be More Serious Than You Think