FDA

Robotics Koh Young gets OK from FDA for brain surgery robot

Koh Young Technology Inc., a South Korean developer of 3D optical inspection devices used in electronics manufacturing, said on Monday it got 501K...

Bio & Pharma JLK gets OK from FDA for ICH diagnosis solution

South Korea’s JLK Inc., an AI-based diagnosis solution and platform maker, said on Monday it got 501K approval from the US Food and Drug Admin...

Bio & Pharma Celltrion obtains approval of Steqeyma from FDA

South Korea's Celltrion Inc. said on Wednesday it received new drug submission (NDS) approval from the Food and Drug Administration (FDA) for Steq...

Bio & Pharma Noul's miLab registered FDA's Class I

South Korea's Noul Co., an in-vitro diagnostics maker and artificial intelligence (AI)-based blood and cancer diagnostic platforms company, said on ...

Bio & Pharma Yuhan’s lung cancer drug clears FDA hurdle for global debut

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...

Bio & Pharma Celltrion gets FDA nod for Keytruda copy's phase 3 clinical trials

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

Bio & Pharma JLK gets FDA OK for prostate cancer diagnosis AI solution

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 ...

Bio & Pharma Investors dump Korean biotech HLB stocks on FDA rejection

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

Bio & Pharma Aprogen gets OK Phase 3 trials in India for Herceptin biosimilar

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

Bio & Pharma MedPacto gets FDA OK for colorectal cancer drug clinical trial

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...

Bio & Pharma CGBio gets FDA approval for Novosis Putty

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...

Bio & Pharma ToolGen gets FDA approval for TGT-001 as ODD

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

Bio & Pharma GC Biopharma gets FDA approval for Alyglo

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

Bio & Pharma SK Bioscience applies Phase 3 trials in US for pneumococcal vaccine

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

Bio & Pharma SK Biopharm gears up to boost epilepsy drug sales in Europe

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

Artificial intelligence Lunit gets FDA approval for AI cancer diagnosis solution

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

Bio & Pharma Gencurix gets FDA OK for breast cancer prognosis analysis device

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

Bio & Pharma NKMax to perform first tests on dementia cell therapy in US

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...

Bio & Pharma Samsung Bioepis gets FDA OK for its interchangeable biosimilar

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

Bio & Pharma Celltrion gets FDA approval for Remsima SC

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

Artificial intelligence Vuno's brain imaging AI medical device secures FDA certification

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

Bio & Pharma Yungjin Pharm's new drug candidate gets Fast Track from FDA

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...

Bio & Pharma Hugel resubmits application to FDA for botulinum toxin product

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

Bio & Pharma S.Korea's CGBio gets FDA approval for spinal implant

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

Bio & Pharma Raphas microneedle passes US FDA's cGMP inspection

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

Bio & Pharma Ildong Bioscience gets US FDA OK for probiotic raw materials

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

Bio & Pharma LegoChem Bio receives FDA approval for phase 1,2 trials of LCB84

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

Bio & Pharma Huons’ 2% lidocaine gets approval from FDA

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

Bio & Pharma Hanmi Pharm's Efinopegdutide gets Fast Track Designation from FDA

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

Bio & Pharma Celltrion gets FDA approval for Humira biosimilar CT-P17

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