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Kazia Therapeutics gets US RPDD for paxalisib in childhood brain cancer

Kazia Therapeutics gets US RPDD for paxalisib in childhood brain cancer

Kazia Therapeutics, an Australian biotech company, has secured the rare pediatric disease designation (RPDD) for paxalisib (formerly GDC-0084) from the US Food and Drug Administration (FDA) for the treatment of diffuse intrinsic pontine glioma (DIPG). Diffuse intrinsic pontine glioma is considered to be a rare and highly-aggressive childhood brain cancer. The rare pediatric disease designation […]

Farxiga : AstraZeneca gets FDA fast track status for heart failure after MI

AstraZeneca has secured fast track designation for Farxiga (dapagliflozin) in the US for its use in reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in adults after an acute myocardial infarction (MI) or heart attack. The fast track designation for the oral once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor is based on […]

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Ascentage Pharma gets FDA ODD for APG-2575 in Waldenström macroglobulinemia

Ascentage Pharma has been granted orphan drug designation (ODD) for its Bcl-2 inhibitor APG-2575 from the US Food and Drug Administration (FDA) for the treatment of Waldenström macroglobulinemia (WM). The orally administered Bcl-2 selective inhibitor that has been designed for the treatment of a range of hematologic malignancies by selectively inhibiting Bcl-2 to restore the […]

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BNT162b1 and BNT162b2 Covid-19 vaccine candidates get FDA fast track status

Pfizer and BioNTech said that BNT162b1 and BNT162b2, two vaccine candidates developed to give protection against the SARS-CoV-2 virus have been given the fast track designation from the USFood and Drug Administration (FDA). The two vaccine candidates are part of the four investigational vaccine candidates that are being jointly developed by the companies under their […]

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Deciphera gets Qinlock FDA approval for fourth-line advanced GIST

Qinlock FDA approval : Deciphera Pharmaceuticals has been granted approval from the US Food and Drug Administration (FDA) for Qinlock (ripretinib) in advanced gastrointestinal stromal tumor (GIST) in adult patients who had prior treatment with three or more kinase inhibitors, including imatinib. The decision from the FDA marks Qinlock as the first drug approved in […]

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Roche cobas HPV test for cervical screening gets FDA nod for use on cobas 6800/8800 Systems

Swiss healthcare company Roche has bagged approval from the US Food and Drug Administration to use its cobas HPV test on the fully automated cobas 6800/8800 Systems for detecting cervical cancer in women. The cobas HPV test has been designed to detect the presence of high-risk human papillomavirus (HPV) DNA in cervical samples from women […]

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Thermo Fisher coronavirus diagnostic test gets FDA’s emergency use order

Thermo Fisher Scientific has been granted an emergency use authorization (EUA) for its coronavirus diagnostic test from the US Food and Drug Administration (FDA). The FDA authorization allows Thermo Fisher Scientific’s COVID-19 diagnostic test that can be immediately used by CLIA high-complexity laboratories in the US for the detection of nucleic acid from SARS-CoV-2, the […]

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Sorrento Therapeutics turns down $993m takeover bid from private equity firm

Sorrento Therapeutics, a California-based biopharma company, has turned down a takeover bid worth about $993 million from an undisclosed private equity fund, as per the latest pharma acquisition news. Earlier this month, the US biopharma company was offered $7.00 per share for the acquisition of a majority stake or 100% in the former. Sorrento Therapeutics […]

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TenNor Therapeutics gets FDA orphan drug status for TNP-2092 in prosthetic joint infections

TenNor Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its multitargeting drug conjugate TNP-2092 for the treatment of prosthetic joint infections. According to the Chinese biopharma company, biofilm infections associated with prosthetic joints, central venous catheters, artificial heart valves, and other medical devices has become a huge challenge. […]

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Allergan bags Ubrelvy FDA approval for migraine treatment

Ubrelvy FDA approval : Irish pharma company Allergan has bagged approval from the US Food and Drug Administration (FDA) for Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura in adults. Aura is a sensory phenomenon or visual disturbance. Ubrelvy is now the first orally-administered calcitonin gene-related peptide (CGRP) receptor […]

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