prestige biopharma fda
Scope
Date
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Bio & Pharma
Biden’s move to beef up US bio industry poses threat to Korean firms
President Joe Biden’s plan to support the US biomanufacturing infrastructure aimed at containing China’s clout is posing a threat to Sou...
Sep 14, 2022 (Gmt+09:00)
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Bio & Pharma
Hanmi’s anti-cancer drug Rolontis gets FDA approval; US sale via Spectrum
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...
Sep 13, 2022 (Gmt+09:00)
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Bio & Pharma
Korean bio firms look to pills, patches for people who fear needles
Getting shots of a drug or vaccine over a long period is not easy for many people.That's probably why global biopharmaceutical companies and biotech...
Aug 24, 2022 (Gmt+09:00)
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Bio & Pharma
LG Chem receives FDA nod for CUE-102 cancer treatment phase 1 trials
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...
May 13, 2022 (Gmt+09:00)
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Bio & Pharma
Medytox-Hugel dispute over botox strain intensifies with ITC probe
A legal dispute over a botox strain between South Korean pharmaceutical company Medytox Inc. and its crosstown rival Hugel Inc. has intensified with...
May 03, 2022 (Gmt+09:00)
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Bio & Pharma
FutureChem seeks FDA nod for prostate cancer radiopharma trials
FutureChem Co., a South Korean radiopharmaceutical company, is seeking the US Food and Drug Administration’s approval for clinical tests of it...
Apr 20, 2022 (Gmt+09:00)
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Bio & Pharma
FDA to review Hanmi Pharmaceutical’s Rolontis for marketing approval
The US Food and Drug Administration has begun reviewing a medicine developed by South Korea’s Hanmi Pharmaceutical Co. for marketing authoriza...
Apr 13, 2022 (Gmt+09:00)
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Bio & Pharma
Korea Hanmi to launch blockbuster hypertension drug in China
South Korea’s Hanmi Pharmaceutical Co. is set to launch its blockbuster high blood pressure drug Amosartan in China, the world’s largest...
Mar 11, 2022 (Gmt+09:00)
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COVID-19
Celltrion wins COVID-19 treatment approval from Europe
South Korea’s pharmaceutical giant Celltrion Inc. has won final approval for its COVID-19 treatment Regkirona from the European Commission, a ...
Nov 15, 2021 (Gmt+09:00)
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Bio
Sartorius to invest $300 mn in bio material, equipment plant in Korea
Sartorius AG, German laboratory equipment and raw material maker, is slated to invest $300 million in the next three years to build a plant in South...
Nov 03, 2021 (Gmt+09:00)
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COVID-19
Samsung Biologics-made Moderna vaccine available to Koreans this week
Moderna Inc.’s COVID-19 vaccine first produced by Samsung Biologics Co. under a contract manufacturing organization (CMO) service will be avai...
Oct 27, 2021 (Gmt+09:00)
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Biosimilars
Samsung Bioepis gets FDA approval for Lucentis biosimilar Byooviz
Samsung Bioepis Co., a leading South Korean biopharmaceutical company, has received approval from the US Food and Drug Administration for its Byoovi...
Sep 23, 2021 (Gmt+09:00)
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IPOs
World’s top COVID-19 test kit maker draws $28 bn in IPO subscriptions
The IPO of SD Biosensor Inc., which has sold the most COVID-19 test kits in the world -- selling more than 700 million kits from February 2020 to Ma...
Jul 09, 2021 (Gmt+09:00)
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Biopharma CMO
Moderna deal shows Korea’s prowess as global hub for biopharma CMO
South Korea is emerging as a global hub for the contract manufacturing of biopharmaceuticals following its latest deal to procure COVID-19 vaccines ...
Dec 30, 2020 (Gmt+09:00)
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Robotics
Korea's first neurosurgery robot to debut; to seek FDA approval
Koh Young Technology Inc., a 3D inspection device maker in South Korea, has commercialized a neurosurgical robotics system for the second time in the ...
Jun 22, 2020 (Gmt+09:00)
Latest News
- 1 BYD’s Atto 3 overtakes Tesla’s Model Y as best-selling EV in South Korea
- 2 Korea’s top cinema chains seek merger to counter box office slump
- 3 S.Korea’s GEPS to commit $143 million to foreign mid-cap buyout funds
- 4 CJ CheilJedang to open $72 mn dumpling plant in Japan
- 5 LG Electronics breaks ground on $600 million home appliance plant in India