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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. […]

Arena Pharmaceuticals’ APD418 gets FDA fast track status in decompensated heart failure

Arena Pharmaceuticals has secured that fast track designation for its drug candidate APD418 from the US Food and Drug Administration (FDA) for the treatment of decompensated heart failure (DHF). APD418 is a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope. According to the San Diego-based biopharma company, APD418 is a selective antagonist that has been designed […]

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Alexion discloses plan for CHAMPION-ALS clinical trial of ULTOMIRIS

Alexion Pharmaceuticals has revealed plans for initiating the CHAMPION-ALS clinical trial, a phase 3 study to evaluate ULTOMIRIS (ravulizumab) for the treatment of amyotrophic lateral sclerosis (ALS). The late-stage clinical trial, which will be held globally by the US pharma company for 50 weeks, will feature nearly 350 adults across a broad patient population. The […]

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Lilly to acquire US dermatology drug company Dermira for $1.1bn

Lilly acquisition of Dermira : US pharma giant Eli Lilly and Company (Lilly) has agreed to acquire California-based dermatology drug company Dermira for about $1.1 billion in an all-cash deal as per the latest pharma acquisition news. Dermira, which is being acquired for $18.75 per share, has been engaged in developing dermatology products for the […]

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Carmell Therapeutics gets IND clearance for CT-101 bone healing accelerant

Carmell Therapeutics has secured clearance from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for CT-101, its first product, which is a bone healing accelerant (BHA). The Pennsylvania biotech company is engaged in the development and commercialization of plasma-based bioactive materials (PBMs) to speed up bone and soft tissue […]

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Biotricity completes development of Biopatch ECG patch platform

Biotricity said that it has wrapped up development of Biopatch, a new ECG patch platform for cardiac patients with fewer complications. The US medical technology company has developed the new ECG patch platform in a miniaturized form factor having three standard electrodes, with no lead wires. Biotricity is an extension of the company’s Bioflux device, […]

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LIAISON QFT-Plus automated screening solution gets FDA nod for TB detection

Qiagen and DiaSorin have secured approval from the US Food and Drug Administration (FDA) to use QuantiFERON-TB Plus (QFT-Plus automated screening solution) on the latter’s LIAISON platforms for detecting latent tuberculosis (TB). With the FDA approval, Qiagen and Diasorin can perform laboratory automation for latent TB screening, which will support the conversion from tuberculin skin […]

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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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Micro Labs, Mylan secure FDA approval for first generics of Eliquis

Micro Labs and Mylan Pharmaceuticals have secured approval from the US Food and Drug Administration (FDA) for two applications for the first generics of Eliquis (apixaban) tablets to cut down the risk of stroke and systemic embolism in patients having nonvalvular atrial fibrillation. Apixaban is also indicated for the preventive treatment of deep vein thrombosis […]

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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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