FDA approval

HD Korea Shipbuilding & Offshore Engineering and HD Hyundai Heavy Industries Co. have secured Approval in Principle (AIP) from the UK's Lloyd's ...

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 VaxCell Biotherapeutics Co. (VaxCell-Bio) on Tuesday announced its application for approval for Vaxleukin-15, an anti-cancer dru...

South Korea’s Hanmi Pharmaceutical Co. on Monday said the Ministry of Food and Drug Safety approved Phase 3 clinical trials for the company&...

South Korea’s biosimilar drugmaker Celltrion group on Monday moved one step closer to the planned combination of its three major affiliates wi...

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 Korean biotech company Curocell Inc. on Sunday said it will apply for approval from the Ministry of Food and Drug Safety in September next yea...

South Korea’s Daewoong Pharmaceutical on Wednesday said its gastroesophageal reflux (GER) disease drug Fexuclue (active ingredient fexuprazan ...

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 biopharmaceutical company Celltrion Inc. announced on Tuesday that it has secured approval from the Japanese Ministry of Health, Labou...

Korean Air Lines Co. may give up the cargo business of Asiana Airlines Inc. and four of its lucrative routes in Europe in an all-in bet as the marri...

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...

The green hydrogen Nujio’qonik project in Canada, a venture that South Korea's SK Ecoplant is taking part in, has secured approval to use go...

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

South Korea’s Hyundai Steel on Wednesday said its Ulsan Factory 2 in the southern coastal city of Ulsan received certification as an offshore ...

SM Korealine Co., a unit of SM Group's maritime division, announced on Monday that its subsidiary Korealine LNG, has obtained approval for self-sail...

South Korea's Daewoong Pharmaceutical Co. announced on Friday that it has submitted an application for regulatory approval of its new diabetes treat...

Poland has started an approval process to build a nuclear power plant consisting of South Korean reactors, according to foreign media reports, despi...

SK Bioscience Co., the drug-making unit of South Korea’s SK Group, on Wednesday shipped SKYCellflu, its vaccine for the common flu, for the fi...

South Korean biopharmaceutical company Celltrion Inc. announced on Tuesday that it has received approval from the European Medicines Agency (EMA) fo...

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

New drug development company ABL Bio Inc. announced on Thursday that it has received approval from the Ministry of Food and Drug Safety of South Kor...

KT Corp., South Korea’s leading telecommunications carrier, reported better-than-expected earnings in the second quarter on strong results for...

South Korea’s KB Kookmin Bank on Sunday said it received final approval on Friday from Cambodia’s Ministry of Commerce to launch the int...

South Korea’s CJ Logistics on Wednesday said it obtained the certification CEIV Pharma, or the Center of Excellence for Independent Validators...

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 GC Biopharma Corp. announced on Wednesday that its quadrivalent influenza vaccine "GC Flu Quadrivalent" has received approval from Egy...

Corentec Co., a South Korean company that develops artificial joints and spinal implants, is making a full-fledged entry into the Japanese market. T...

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