Home » Archives by category » Pharma Regulatory News
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 […]

Continue reading …
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 […]

Continue reading …
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 […]

Continue reading …
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 […]

Continue reading …
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 […]

Continue reading …
Astellas, Seattle Genetics bag Padcev FDA approval for advanced urothelial cancer

Padcev FDA approval : Astellas Pharma and Seattle Genetics have bagged accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) for the treatment of advanced urothelial cancer, the most common form of bladder cancer. Padcev, which has been co-developed by the two pharma companies, is a Nectin-4-directed antibody and microtubule […]

Continue reading …
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, […]

Continue reading …
Incyte secures FDA priority review for pemigatinib in cholangiocarcinoma

Delaware-based pharma company Incyte has secured priority review for pemigatinib from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic cholangiocarcinoma. The priority review for pemigatinib is for the treatment of the condition in previously treated patients having FGFR2 fusions or rearrangements. Cholangiocarcinoma is a rare cancer that occurs […]

Continue reading …
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 […]

Continue reading …
Page 1 of 15123Next ›Last »