FDA

A new lung cancer treatment developed by South Korea’s Yuhan Corp. has secured approval from the US Food and Drug Administration (FDA) as a co...

Celltrion Inc., South Korea’s biosimilar giant, will proceed with phase 3 trials for global blockbuster drug Keytruda’s copycat CT-P51, ...

South Korea’s JLK Inc., an AI-based diagnosis solution and platform maker, announced on Monday that it got approval from the US Food and Drug ...

HLB Co. and its affiliate stocks tumbled on Friday on news that the South Korean biotech group’s highly anticipated new cancer treatment Rivoc...

South Korea’s biopharmaceutical company Aprogen Inc. announced on Monday that its Phase 3 clinical trial for a biosimilar of Herceptin (trastu...

South Korea's biotech company MedPacto Inc. announced on Tuesday that it has got approval from the US Food and Drug Administration (FDA) for its I...

South Korea's bio-regenerative medical firm CGBio announced on Tuesday that its Novosis Putty has been designated as a breakthrough device by the US...

South Korean genome editing developer ToolGen Inc. announced on Monday that its application for orphan drug designation (ODD) of the gene correction...

South Korea’s GC Biopharma Corp. announced on Monday that it received approval from the US Food and Drug Administration (FDA) for the immuno...

South Korea's SK Bioscience Co. announced on Monday that it submitted the Investigational New Drug (IND) application for the Phase 3 clinical trial ...

SK Biopharmaceuticals Co. is gearing up to explore the European market for its flagship epilepsy drug Cenobamate, while looking for new mergers and ...

South Korean medical AI company Lunit said on Tuesday its Lunit Insight DBT, an AI imaging diagnosis solution aiding in breast cancer diagnosis, has...

South Korean biotech company Gencurix Inc. announced on Wednesday its subsidiary GenoBio has received approval from the US Food and Drug Admini...

NKMax Co., South Korea's largest developer of natural killer (NK) cell therapies, will conduct its first clinical trials in the US for its candidate...

Byooviz, a biosimilar of the macular degeneration treatment Lucentis and made by South Korea’s Samsung Bioepis, has received official design...

South Korea's Celltrion Inc. announced on Monday it received a new drug approval for an autoimmune disease treatment Remsima SC (active ingredient i...

South Korea's medical device startup Vuno announced on Tuesday that its AI-powered brain quantification device Vuno Med-DeepBrain has received the 5...

South Korea's Yungjin Pharm has secured Fast Track designation from the US Food and Drug Administration (FDA) for its new drug candidate KL1333, des...

South Korea's biopharmaceutical company Hugel Inc., announced on Friday that it has resubmitted applications to the US Food and Drug Administration ...

CGBio, a South Korean bio-regenerative medical company, announced on Monday that its "Advanced LumFix spinal fixation system," an implant and surgic...

South Korea's microneedle maker Raphas Co. announced on Wednesday that it has passed the Current Good Manufacturing Practice (cGMP) inspection by ...

South Korea's Ildong Bioscience on Thursday said two of its probiotic raw materials received the certification generally recognized as safe (GRAS) f...

South Korean pharmaceutical firm LegoChem Biosciences Inc. announced on Thursday that it has received approval from the US Food and Drug Administrat...

South Korean pharmaceutical firm, Huons Co., announced on Monday that it has secured another significant regulatory milestone in the US with the Foo...

Merck, known as MSD outside the United States and Canada, announced on Monday that Efinopegdutide, a technology transferred from the South Korean ph...

South Korean biopharmaceutical company Celltrion Inc. announced on Wednesday that it has obtained product approval from the US Food and Drug Adminis...

HLB Co. announced on May 17 that it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of Rivo...

The US Food and Drug Administration (FDA) has recommended that consumers discard select models of Pilot COVID-19 self-diagnostic test kits sold on t...

South Korea's largest food and bio company CJ CheilJedang Corp. announced on Thursday that its biodegradable material polyhydroxyalkanoate (PHA) has...

Verismo Therapeutics, a US affiliate of South Korean pharmaceutical firm HLB Co., has received fast-track designation from the US Food and Drug Admi...