Spectral AI Inc. (MDAI) Poised for FDA Approval with Revolutionary DeepView System
We recently published a list of 10 AI Stocks Dominating the News This Week. In this article, we are going to take a look at ...
Nasdaq2d
Milestone Pharma: FDA Issues CRL Regarding New Drug Application For CARDAMYST Nasal Spray
The FDA highlighted two key Chemistry ... views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Nasdaq4d
FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib (Revised)
Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple ...
Nasdaq3d
DXCM Stock Falls as FDA Warnings Raise Concern for 15-Day G7 Approval
DexCom DXCM is facing regulatory scrutiny following a warning letter recently posted by the FDA. This could affect the approval of the company’s upcoming 15-day G7 continuous glucose monitor (CGM).
Nasdaq3d
SLNO Stock Rallies on FDA Approval of Prader-Willi Syndrome Drug
Shares of Soleno Therapeutics SLNO have rallied 37% in the premarket hours today following the FDA approval of Vykat XR (diazoxide choline) extended-release tablets for treating hyperphagia in ...
Nasdaq3d
Soleno Therapeutics Gets FDA Approval For VYKAT XR To Treat Hyperphagia In Prader-Willi Syndrome
According to the company, the FDA approval of VYKAT XR was based on ... of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in ...
Nasdaq13d
Travere Therapeutics Submits sNDA for FILSPARI as Potential First FDA-Approved Treatment for FSGS
Inc., (Nasdaq: TVTX) today announced the Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking priority review for traditional ...
Nasdaq9d
Glenmark Gets FDA Approval For Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC)
The FDA has determined it to be bioequivalent to ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Nasdaq5d
Sanofi's Tolebrutinib Under FDA Priority Review For Treating NrSPMS & Slowing Disability Progression
The target action date for the FDA decision is September 28 ... opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in ...
Nasdaq12d
Can-Fite: FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient
Such investigational drug has not yet been approved by the FDA. Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with ...
Nasdaq11d
Liquidia Corporation Advances YUTREPIA™ Towards Final FDA Approval While Strengthening Financial Position by Up to $100 Million
YUTREPIA received tentative FDA approval for treating pulmonary arterial ... Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with ...
Nasdaq5d
FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib
Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple ...