Medscape4m
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 ...
Zacks.com on MSN1h
Axsome Shares Rise 19% in a Month: What's Driving the Rally?
Axsome Therapeutics’ AXSM shares have rallied 19.4% in the past month against the industry’s decrease of 0.2%, driven by ...
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 ...
Taiwan News4h
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that its Marketing Authorization Application (MAA) for ...
Managed Healthcare Executive19h
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.
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 ...
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 ...
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
Scilex seeks FDA nod for ELYXYB in acute pain management
PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a pharmaceutical company with a current market capitalization of ...
Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...