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Home » Topics » Regulatory » Fast track

Fast track
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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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Plus Therapeutics’ Rhenium Nanoliposomes are fast tracked in glioblastoma

Sep. 15, 2020
By Lee Landenberger
The FDA has granted Plus Therapeutics Inc. fast track designation for its lead candidate, Rhenium Nanoliposomes (RNL), for treating recurrent glioblastoma, propelling it into the sixth cohort of a phase I dose-finding trial.
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FDA Approved seal

Viiv wins FDA approval for new late-line HIV drug

July 6, 2020
By Michael Fitzhugh
Viiv Healthcare Ltd., late Thursday, won FDA approval for Rukobia (fostemsavir), a gp120-directed attachment inhibitor for the treatment of adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The drug was reviewed under FDA's fast track and breakthrough therapy status programs.
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Carmell-bone-healing-accelerant.png

FDA grants fast track designation to Carmell Therapeutics bone healing accelerant

April 30, 2020
By Annette Boyle
Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.
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Carmell-bone-healing-accelerant.png

FDA grants fast track designation to Carmell Therapeutics bone healing accelerant

April 29, 2020
By Annette Boyle
Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.
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