FDA approval

Daewoong Pharmaceutical said on Wednesday that its botulinum toxin formulation Nabota (overseas brand name: Nuceiva) won approval in Australia on Ja...

K-pop behemoth SM Entertainment Co. said on Jan. 20 it has decided to tap Lee Chang-hwan, the CEO of local activist fund Align Partners Capital Mana...

South Korea's energy equipment maker Doosan Enerbility Co. has obtained the green light in participating in the domestic nuclear storage cask market...

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...

Celltrion Inc. announced on Monday it applied to the European Medicines Agency (EMA) for approval of a 20 mg/0.2 mL formulation of Yuflyma, a biosim...

South Korea's biomedicine firm S.Biomedics said on Friday that it has won approval from the Ministry of Food and Drug Safety for phase 1 and 2a clin...

South Korean biohealth company HK inno.N said on Wednesday that it has received an item approval for K-CAB, a new drug for gastroesophageal reflux d...

SK Bioscience Co. said on Monday that its shingles vaccine Sky Zoster has been given approval by Malaysia's National Pharmaceutical Regulatory Age...

South Korea's biosimilar heavyweight Celltrion Inc. has obtained permission from the Canadian health ministry to sell anticancer biosimilar Vegzelma...

South Korea's most valuable biopharmaceutical company Celltrion Inc. said on Tuesday that its antibody biosimilar Remsima (ingredient: infliximab) h...

South Korean molecular diagnostics companies are increasingly buying high-quality laboratories in the US that meet federal regulatory standards in a...

GI Cell, a South Korean developer of immune cell therapy products, received a human cell and others management license from South Korean regulatory,...

The merger between South Korea's two leading airlines Korean Air Lines Co. and Asiana Airlines Inc. passed a hurdle as China's antitrust watchdog ga...

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...

Samsung Heavy Industries, a major shipbuilder in South Korea, said on Tuesday that its boil-off gas recovery system (BReS) for LNG-powered vessels h...

The Korean Fair Trade Commission said on Monday that it had conditionally approved LX International Corp.'s bid to acquire Hankuk Glass Industries (...

South Korea's SK Telecom Co. on Thursday said the International Telecommunication Union's Telecommunication Standardization Sector (ITU-T) approved ...

The news of US mobile device giant Apple launching its Apple Pay service in South Korea this month sent the share prices of companies that assist th...

DAEWOONG PHARMACEUTICAL has received domestic approval for its diabetes drug Envlo with the active ingredient enavogliflozin, the second straight ye...

Vuno Inc., a South Korean artificial intelligence-powered medical solutions provider, said on Tuesday that Vuno Med-Fundus AI has received marketing...

The UK's top watchdog for market competition on Monday accepted corrective measures submitted by Korean Air Lines Co. on its proposed takeover of As...

South Korea’s Hyundai Engineering Co., the plant engineering and construction unit of Hyundai Motor Group, said Monday it has completed its co...

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...

S-Oil Corp., the South Korean unit of Saudi Arabian Oil Co., will approve the much-touted 8 trillion won ($6 billion) Shaheen project to expand its ...

Samsung Electronics Co.'s leader Jay Y. Lee was promoted as the company's chairman on Oct. 27.Samsung Electronics' board of directors approved the a...

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...

Celltrion Inc. secured Japan’s approval for sales of its cancer treatment biosimilar CT-P16, a move to help the South Korean biopharmaceutical...