prestige biopharma fda

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...

Prestige Biologics Co., a South Korean biopharmaceutical contract development and manufacturing organization (CDMO) company, is expanding its CDMO b...

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 ...

South Korea's EuBiologics Co., the world's leading cholera vaccine company, has signed a joint production agreement with GC Biopharma Corp. to produ...

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

Prestige Biopharma, a Singapore-based biopharmaceutical company with operations in South Korea and the US, announced on Tuesday that it will partici...

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

South Korea's GC Biopharma Corp. on Monday announced on Monday that it has a supply contract with Blau Farmacêutica, a Brazilian pharmaceutica...

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...

GC Biopharma Corp., a South Korean pharmaceutical company, announced on Thursday that it has received approval from the Indonesian Ministry of Healt...

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

CrystalGenomics Inc., South Korea’s first-generation biopharma venture company, will sell new shares worth 58 billion won ($44 million) in a b...

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...

Global pharmaceutical company Merck is considering a plan to establish a biopharmaceutical raw material production facility in Daejeon.South Korean ...

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

Dongwon Industries Co., South Korea’s No. 1 canned tuna producer, has backed out of a deal estimated between $400 million and $500 million to ...

South Korea's pharmaceutical firm GC Biopharma Corp. said on Monday that it has won a $44.3 million (57.9 billion won) order for flu vaccines in a d...

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...