FDA rejection

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...

South Korea’s antitrust body dismissed corrective measures proposed by US chipmaker Broadcom Inc. to avoid penalties over its alleged unfair b...

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...

South Korea’s Supreme Court on Thursday reaffirmed the country’s largest-ever penalty of 1.03 trillion won ($800 million) imposed on Qua...

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

Prestige Biopharma, a biopharmaceutical company in South Korea, announced on Thursday that their pancreatic cancer antibody drug, PBP1510 (Ulenistam...

Koh Young Technology Inc., a South Korean developer of 3D optical inspection devices used in electronics manufacturing, is slated to enter the US me...

Curexo, a South Korean medical robot company, said on Tuesday that it had unveiled its artificial joint surgery robot "TMAX" at AAOS 2023, the world...

South Korean drugmaker Daewoong Pharmaceutical Co. said on Tuesday it had launched its botulinum toxin product Nabota in Germany and Austria through i...

South Korea's bio-esthetic pharmaceutical company Jetema Co. will hold clinical trials in the US to advance to the American market, the world's bigg...

HLB Therapeutics Co. announced Thursday that Sofjec, a syringe produced by its subsidiary Hwajin Medical, has been approved for sale by the US Food ...

South Korea's HLB Co. announced on Thursday that the combination therapy of its drug candidate rivoceranib and Jiangsu Hengrui Pharmaceuticals Co., ...

South Korea's bio firm GC Cell announced on Wednesday that its US affiliate Artiva Biotherapeutics has received fast-track designation from the US F...

GC Biopharma Corp. said on Wednesday that its Sanfilippo type A treatment, which is under joint development with Novel Pharma, a bio-venture special...

South Korean biotech company MedPacto Inc. ’s Vactosertib monotherapy for osteosarcoma patients has been designated as a fast-track developmen...

CJ Bioscience, an independent red bio (pharmaceutical and healthcare) subsidiary of CJ CheilJedang Corp., said on Monday it has submitted a phase 1 ...

Celltrion Ltd. said on Friday it had applied the previous day for permission from the US Food and Drug Administration (FDA) for Remsima SC, an autoi...

Celltrion Inc. said it has confirmed the effectiveness and safety of Remsima SC in its third-phase global clinical trials, conducted on 438 patients...

South Korea's Mezzion Pharma will seek to get the oral medicine Udenafil to treat side effects from heart surgery, planning to clinical trials in th...

South Korea’s chemicals giant LG Chem Ltd. announced on Oct. 18 that it will acquire AVEO Pharmaceuticals Inc., a Nasdaq-listed US biotech fir...