FDA Archives - Page 138 of 220

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Aldeyra Therapeutics Announces Primary Vitreoretinal Lymphoma Pre-NDA Meeting With FDA; Company Intends To Request Priority Review Designation

December 1, 9:05 AM

Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) (Aldeyra) today announced that, following the recent receipt of official minutes from its pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration

ALDX

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FDA
News

NLS Pharmaceutics Announces Notice Of Allowance For U.S. Patent Covering Mazindol For Opioid Dependence And Substance Use Disorder

By Benzinga Newsdesk

December 1, 9:03 AM

More than 100,000 deaths in the U.S. alone each year due to overdose Global Opioid Use Disorder market projected to be approximately $5 Billion by 2028 Mazindol classified by the U.S. Drug Enforcement

NLSP

2 minute read

Oncolytics Biotech Receives FDA Fast Track Designation For The Treatment Of Advanced/Metastatic Pancreatic Cancer

By Benzinga Newsdesk

December 1, 8:40 AM

Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1

ONCY

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Orchard Therapeutics Announced Swissmedic Validation of the Marketing Authorization Application for Libmeldy (atidarsagene autotemcel)

By Charles Gross

December 1, 8:10 AM

Orchard Therapeutics (NASDAQ: ORTX), a global gene therapy leader, today announced its marketing authorization application (MAA) for Libmeldy® (atidarsagene autotemcel) has been accepted for evaluation by the Swiss Agency for Therapeutic Products (Swissmedic) for the potential treatment of eligible patients with early-on

ORTX

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Compugen’s COM701 In Dual And Triple Combination Demonstrates Preliminary Anti-Tumor Activity And Immune Activation In Platinum Resistant Ovarian Cancer Patients

By Benzinga Newsdesk

December 1, 8:02 AM

At the time of abstract data cutoff, COM701+ nivolumab + BMS-986207 (anti-TIGIT) demonstrated encouraging 20% overall response rate and 40% disease control rate in heavily pretreated patients with

CGEN

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Regeneron’s Evkeeza Under FDA Priority Review For Younger Kids With Inherited Form Of High Cholesterol

By Vandana Singh

November 30, 11:51 AM

The FDA has accepted Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) supplemental marketing application seeking approval for Evkeeza (evinacumab-dgnb) as an adjunct to other…

REGN

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Aeglea Nosedives After Clinical Update On Investigational Candidate For Rare Metabolism Disease

By Vandana Singh

November 30, 11:38 AM

Aeglea BioTherapeutics Inc (NASDAQ: AGLE) has appointed Jeffrey M. Goldberg as president, chief executive officer, and a board member, effective November 29, 2022.

AGLE

2 minute read

Vistagen Receives FDA “Study May Proceed” Letter Under Its Investigational New Drug Application For PH10 To Treat Major Depressive Disorder

By Benzinga Newsdesk

November 30, 9:38 AM

Vistagen, (NASDAQ:VTGN) a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today

VTGN

11 minute read

Reported Late Tuesday, Eisai And Biogen Present Full Results Of Lecanemab Phase 3 Confirmatory Clarity AD Study For Early Alzheimer’s Disease At Clinical Trials On Alzheimer’s Disease Conference: Primary And Key Secondary Endpoints Were Changed From Ba…

By Benzinga Newsdesk

November 30, 2:20 AM

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: , Cambridge, Massachusetts, CEO: , Christopher A.

BIIB

2 minute read

Sorrento Releases Topline Results From The Phase I Study Completed In Australia And Preliminary Results From A Phase Ib Study In China With STI-1558, An Oral M(pro) Inhibitor As A Standalone Treatment For COVID-19 Without The Need For Ritonavir Boostin…

By Benzinga Newsdesk

November 29, 3:07 PM

Topline safety and pharmacokinetic (PK) data from the Phase I single ascending dose (SAD)/multiple ascending dose (MAD) study of STI-1558 in 58 healthy volunteers in Australia are now available. The SAD portion of the

SRNE