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Deciphera gets Qinlock FDA approval for fourth-line advanced GIST

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 […]

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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FDA rejects Correvio Pharma’s anti-arrhythmic drug Brinavess

Correvio Pharma said that the US Food and Drug Administration (FDA) decided not to approve its anti-arrhythmic drug Brinavess (vernakalant IV). In this connection, the Canadian specialty pharma company has been issued a complete response letter (CRL) from the FDA stating that it cannot approve the new drug application (NDA) for Brinavess in its present […]

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Amgen, Allergan file BLA to FDA for Rituxan biosimilar ABP 798

Rituxan biosimilar ABP 798 : US biopharma company Amgen and Irish pharma company Allergan have submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Roche’s cancer drug Rituxan (rituximab). Rituxan, which is a CD20-directed cytolytic antibody, has approval across various regions for the […]

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Amarin bags Vascepa FDA approval for reducing cardiovascular risk

Vascepa FDA approval : New Jersey-based Amarin has secured approval from the US Food and Drug Administration (FDA) for a new indication and label expansion for Vascepa (icosapent ethyl) capsules. The FDA has now approved Vascepa as an adjunctive (secondary) therapy to cut down the risk of cardiovascular events in adults having elevated triglyceride levels, […]

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Y-mAbs begins roll-out of BLA of naxitamab to FDA for neuroblastoma

US biopharma company Y-mAbs Therapeutics has submitted the first portions of its biologics license application (BLA) for naxitamab to the US Food and Drug Administration (FDA), seeking the drug’s approval for the treatment of relapsed/refractory high-risk neuroblastoma under the latter’s Rolling Review process. Naxitamab, an anti-GD2 monoclonal antibody, was granted the FDA breakthrough therapy designation […]

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