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Home » Topics » Regulatory » Fast track

Fast track
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Coronavirus, lungs

Healios posts more upbeat data on Multistem cell therapy for ARDS

March 18, 2025
By Marian (YoonJee) Chu
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
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Coronavirus, lungs

Healios posts more upbeat data on Multistem cell therapy for ARDS

March 14, 2025
By Marian (YoonJee) Chu
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
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US FDA grants fast track to Moebius-Sun’s knee OA pain injection

Sep. 10, 2024
By Marian (YoonJee) Chu
The U.S. FDA on Sept. 6 granted fast track designation to MM-II – a novel, non-opioid injectable candidate for knee osteoarthritis (OA) co-developed by Sun Pharmaceutical Industries Ltd. and Moebius Medical Ltd. Mumbai, India-based Sun and Tel Aviv, Israel-based Moebius agreed, under undisclosed terms, to co-develop the novel liposomal non-opioid pain therapy in an exclusive global licensing deal in 2016.
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US FDA grants fast track to Moebius-Sun’s knee OA pain injection

Sep. 9, 2024
By Marian (YoonJee) Chu
The U.S. FDA on Sept. 6 granted fast track designation to MM-II – a novel, non-opioid injectable candidate for knee osteoarthritis (OA) co-developed by Sun Pharmaceutical Industries Ltd. and Moebius Medical Ltd. Mumbai, India-based Sun and Tel Aviv, Israel-based Moebius agreed, under undisclosed terms, to co-develop the novel liposomal non-opioid pain therapy in an exclusive global licensing deal in 2016.
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Mabwell joins ADC breast cancer race as China clears phase II

July 16, 2024
By Marian (YoonJee) Chu
Mabwell Bioscience Co. gained clearance in China to start a phase II study of its novel Nectin4-targeting antibody drug conjugate (ADC), 9MW-2821, for metastatic triple-negative breast cancer.
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Vials of SNB-101

SN Bioscience nabs FDA fast track for lung cancer drug

May 14, 2024
By Marian (YoonJee) Chu
SN Bioscience Co. Ltd., headquartered in Seongnam-si, Gyeonggi-do’s second Pangyo Valley, gained U.S. FDA fast track designation for SNB-101 (SN-38), its new polymer nanoparticle cancer drug candidate for small-cell lung cancer.
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Vials of SNB-101

SN Bioscience nabs FDA fast track for lung cancer drug

May 10, 2024
By Marian (YoonJee) Chu
SN Bioscience Co. Ltd., headquartered in Seongnam-si, Gyeonggi-do’s second Pangyo Valley, gained U.S. FDA fast track designation for SNB-101 (SN-38), its new polymer nanoparticle cancer drug candidate for small-cell lung cancer.
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Ahead of IPO, D&D Pharmatech wins US fast track for MASH drug

April 9, 2024
By Marian (YoonJee) Chu
Building D&D Pharmatech Inc. has been a rollercoaster ride, according to CEO Seulki Lee. The U.S. and Korea-based biotech is on another ascent, having scored U.S. FDA fast track designation for its metabolic dysfunction-associated steatohepatitis (MASH) drug, ahead of its third attempt at a public listing.
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Staphylococcus aureus

US FDA approves antibiotic Zevtera, Basilea seeks US partner

April 4, 2024
By Karen Carey
In a long and winding regulatory road that began with two complete response letters 15 years ago, Allschwil, Switzerland-based Basilea Pharmaceutica Ltd. finally gained U.S. FDA approval of its intravenous cephalosporin antibiotic, Zevtera (ceftobiprole medocaril sodium), to treat Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia.
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Ahead of IPO, D&D Pharmatech wins US fast track for MASH drug

April 4, 2024
By Marian (YoonJee) Chu
Building D&D Pharmatech Inc. has been a rollercoaster ride, according to CEO Seulki Lee. The U.S. and Korea-based biotech is on another ascent, having scored U.S. FDA fast track designation for its metabolic dysfunction-associated steatohepatitis (MASH) drug, ahead of its third attempt at a public listing.
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