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

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. […]

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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FDA approves ApiFix MID-C system for progressive AIS

Israeli medical devices manufacturer ApiFix has bagged approval from the US Food and Drug Administration (FDA) for marketing its minimally invasive deformity correction system (MID-C system) or the treatment of progressive adolescent idiopathic scoliosis (AIS) through a humanitarian device exemption (HDE). Considered to be the most common form of scoliosis, adolescent idiopathic scoliosis impacts 2-3% […]

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FDA clears Biobeat wearable watch and patch for BP measurement

Israeli biotech company Biobeat has secured a 510A clearance from the US Food and Drug Administration (FDA) for its wearable watch and patch for monitoring blood pressure (BP), oxygenation, and heart rate in clinics, hospitals, long term care and at home. The user will have to use one or the other device, while the watch […]

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Global Blood Therapeutics bags Oxbryta FDA approval for sickle cell disease

Oxbryta FDA approval : Global Blood Therapeutics (GBT), a California-based biopharma company, has bagged approval for Oxbryta (voxelotor) tablets from the US Food and Drug Administration (FDA) for sickle cell disease (SCD). The FDA approval of Oxbryta is for the treatment of adults and children, aged 12 years of age and older, who are suffering […]

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Ferring, Blackstone invest $570m in nadofaragene firadenovec gene therapy

Ferring Pharmaceuticals, a Swiss specialty biopharmaceutical group, has teamed up with private investment platform Blackstone Life Sciences to jointly invest more than $570 million in nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy. Currently, nadofaragene firadenovec is in late-stage development for the treatment of patients with high-grade, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC). […]

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