News Medical1h
New approach uses peptides to enhance anti-tumor drug formulations
A team of scientists has developed a groundbreaking approach using specially designed peptides to improve drug formulations.
Medscape10h
FDA OKs Esketamine Nasal Spray Monotherapy for Resistant Depression
The expanded indication allows esketamine nasal spray to be used as a standalone treatment in adults with MDD who have not ...
Govt Decides To Extend Term Of Drug Controller General While Examining 18 Candidates For Post
Explaining the decision to re-employ the current drug controller general of India, the health ministry has told the ...
FDA approves drug application for Lupin’s heart failure therapy
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
Managed Healthcare Executive1d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...
Monthly Prescribing Reference1d
FDA Extends Review of Elamipretide for Barth Syndrome
The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
Healio2d
FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...
Scilex FDA submission for ELYXYB acute pain treatment acknowledged
PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a $77.5 million market cap company known for its focus on non-opioid pain management products, reported that the U.S. Food and Drug ...
BioSpace2d
FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
JD Supra3d
Patent Poetry: Federal Circuit Reverses Novartis Patent Decision
The Federal Circuit has issued a precedential decision reversing a lower court’s decision that certain claims of Novartis’s ...