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Celgene bags Inrebic FDA approval for myelofibrosis

Celgene bags Inrebic FDA approval for myelofibrosis

Inrebic FDA approval : Celgene’s subsidiary Impact Biomedicines, has bagged approval for its oral kinase inhibitor Inrebic (fedratinib) capsules from the US Food and Drug Administration (FDA) for the treatment of certain types of myelofibrosis, a rare bone marrow cancer. Fedratinib FDA approval is for the treatment of adult patients with intermediate-2 or high-risk primary […]

AbbVie secures Rinvoq FDA approval for rheumatoid arthritis

Rinvoq FDA approval : US biopharma company AbbVie has bagged approval from the US Food and Drug Administration (FDA) for its 15mg, daily once oral, small molecule Janus kinase (JAK) inhibitor – Rinvoq (upadacitinib) for the treatment of moderately to severely active rheumatoid arthritis (RA). The FDA approval for Rinvoq is for the treatment of […]

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Neuropore gets FDA orphan drug designation for NPT520-34 for ALS

Neuropore Therapies has secured orphan drug designation for NPT520-34 from the US Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS). The California-based biopharma company said that the orphan drug designation will enable the development of NPT520-34 in the treatment of the debilitating medical condition for which there are not many […]

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TB Alliance bags Pretomanid FDA approval for highly drug-resistant TB

Pretomanid FDA approval : Non-profit organization TB Alliance has secured approval for Pretomanid Tablets in combination with bedaquiline and linezolid from the US Food & Drug Administration (FDA) for the treatment of highly drug-resistant forms of tuberculosis. The combination regimen was approved by the FDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD […]

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NinePoint’s NvisionVLE Imaging System cleared for pancreatic and biliary applications

The US Food and Drug Administration (FDA) has cleared transformative medical device company NinePoint Medical to market NvisionVLE Imaging System for pancreas and bile duct applications, in addition to the previously existing esophageal use. The Optical Coherence Tomography (OCT) imaging platform, NvisionVLE Imaging System, will help gastroenterologists to thoroughly evaluate tissue for regions of interest […]

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Stokes’ STK-001 secures FDA orphan drug designation for Dravet Syndrome

US biotech company Stoke Therapeutics has secured orphan drug designation for its lead product candidate – STK-001 from the US Food and Drug Administration (FDA) for the treatment for Dravet syndrome. Considered to be a severe and progressive genetic epilepsy, Dravet syndrome is characterized by frequent, prolonged and refractory seizures that start within the first […]

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Foamix files NDA seeking FMX103 FDA approval for rosacea

Israeli pharma company Foamix Pharmaceuticals has filed a new drug application (NDA) for FMX103 to the US Food and Drug Administration (FDA) seeking FMX103 FDA approval for moderate-to-severe papulopustular rosacea in patients, aged 18 years and over. Considered to be a common skin condition, rosacea results in redness and visible blood vessels in the face. […]

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Bayer, Orion secures Darolutamide FDA approval for prostate cancer

Darolutamide FDA approval : German pharma giant Bayer and Finnish pharma company Orion have secured approval from the US Food and Drug Administration (FDA) for their non-steroidal androgen receptor inhibitor (ARi) Nubeqa (darolutamide) for the treatment of men having non-metastatic castration-resistant prostate cancer (nmCRPC). The FDA approval of darolutamide was driven on the findings of […]

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Boehringer Ingelheim secures Ofev FDA approval recommendation for SSc-ILD

Ofev FDA approval recommendation: The US FDA’s Arthritis Advisory Committee has recommended approval of Boehringer Ingelheim’s kinase inhibitor Ofev (nintedanib) for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The committee’s Ofev FDA approval recommendation was driven by the findings of the phase 3 SENSCIS trial, held in patients with SSc-ILD, a disease for […]

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NeuroVive secures NeuroSTAT FDA fast track designation for TBI

NeuroSTAT FDA fast track designation : Swedish mitochondrial medicine company NeuroVive Pharmaceutical has secured Fast Track designation from the US Food and Drug Administration (FDA) for NeuroSTAT for the treatment of moderate to severe traumatic brain injury (TBI). NeuroVive said that NeuroSTAT FDA fast track designation will enable the drug’s clinical development and a direction […]

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