Tebipenem HBr, a potential first oral carbapenem antibiotic, will be submitted to the US FDA under a rolling NDA in the first quarter of 2021 for complicated urinary tract infection and acute pyelonephritis.
Spero Therapeutics, Inc. is on track to seek approval of the first oral carbapenem antibiotic in the US, providing a new option for patients with complicated Gram-negative infections currently treated with intravenous antibiotics.
The company said on 8 September that it expects to begin a rolling new drug application for tebipenem pivoxil hydrobromide...
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PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.
The company will ramp up manufacturing of its Jynneos vaccine to meet demand in worst-affected African countries and stockpiling richer nations.
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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