verismo fasttrack fda

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...

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...

South Korea’s Hanmi Pharmaceutical Co. said on Tuesday that Rolontis, an anti-cancer drug it has jointly developed with its US partner, has ob...

LG Chem Life Sciences, the biopharmaceutical unit of LG Chem Ltd., has received the US Food and Drug Administration’s approval for phase 1 cli...

A legal dispute over a botox strain between South Korean pharmaceutical company Medytox Inc. and its crosstown rival Hugel Inc. has intensified with...

FutureChem Co., a South Korean radiopharmaceutical company, is seeking the US Food and Drug Administration’s approval for clinical tests of it...

The US Food and Drug Administration has begun reviewing a medicine developed by South Korea’s Hanmi Pharmaceutical Co. for marketing authoriza...

South Korea’s Hanmi Pharmaceutical Co. is set to launch its blockbuster high blood pressure drug Amosartan in China, the world’s largest...

South Korea’s pharmaceutical giant Celltrion Inc. has won final approval for its COVID-19 treatment Regkirona from the European Commission, a ...

Samsung Bioepis Co., a leading South Korean biopharmaceutical company, has received approval from the US Food and Drug Administration for its Byoovi...

Koh Young Technology Inc., a 3D inspection device maker in South Korea, has commercialized a neurosurgical robotics system for the second time in the ...