FDA Archives - Page 131 of 220

6 minute read

Pharming Announces Interim Analysis Data From Open-Label Extension Study Of Leniolisib In Presentation At The 64th American Society Of Hematology Annual Meeting And Exposition

December 15, 2:05 AM

V. Koneti Rao, MD, shared new evidence of long-term safety and hematologic response in patients who received leniolisib to treat APDS, a rare primary immunodeficiency Interim analysis demonstrated leniolisib to be

PHAR

1 minute read

FDA
News

Miromatrix Medical Says FDA Has Informed Co. That miroliverELAP Investigational New Drug Application For Treatment Of Acute Liver Failure Has Been Placed On Clinical Hold

By Michael Horton

December 14, 6:29 PM

-SEC Filing

MIRO

1 minute read

FDA
News

FDA Grants Emergency Use Authorization For Thermo Fisher Scientific’s Monkeypox Test

By Michael Horton

December 14, 5:13 PM

-Reuters

TMO

1 minute read

Aligos Therapeutics Initiates Dosing With Its Small Interfering RNA (siRNA) Drug Candidate, ALG-125755, In Subjects With Chronic Hepatitis B

By Benzinga Newsdesk

December 14, 5:07 PM

Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported today that dosing with

ALGS

2 minute read

Vigil Neuroscience Announces First Patient Dosed In The IGNITE Phase 2 Clinical Trial To Evaluate VGL101 In Patients With ALSP

By Benzinga Newsdesk

December 14, 5:01 PM

Vigil Neuroscience, Inc. (NASDAQ:VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced that the Company dosed

VIGL

4 minute read

Processa Pharmaceuticals Announces PCS12852 Successfully Improves The Clinical Symptoms Associated With Gastroparesis In Phase 2A Trial

By Benzinga Newsdesk

December 14, 9:34 AM

A 0.5 mg daily dose of PCS12852 administered over 28 days in gastroparesis patients successfully improved gastroparesis symptoms in a clinically meaningful way as defined by greater than a 0.5 reduction in the ANMS

PCSA

1 minute read

MoonLake Immunotherapeutics Screens First Patient In Phase 2 Study Of The Nanobody Sonelokimab In Active Psoriatic Arthritis

By Benzinga Newsdesk

December 14, 9:05 AM

Phase 2 study represents an important step in psoriatic arthritis clinical development, assessing high threshold outcomes across joint and skin domains of this multi-faceted disease Global study to assess efficacy and

MLTX

1 minute read

FDA Adcomm Gives Thumbs Down To Cytokinetics’ Heart Failure Candidate

By Vandana Singh

December 14, 7:40 AM

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8-3 against the approval of Cytokinetics Incorporated’s (NASDAQ:CYTK) heart failure drug, omecamtiv mecarbil.…

CYTK

1 minute read

U.S. FDA Advisors Vote Against Recommending Agency Approve Cytokinetics’ Heart Drug For Treatment Of Heart Failure With Reduced Ejection Fraction

By Michael Horton

December 13, 5:23 PM

-Reuters

CYTK

1 minute read

FDA
News

Vincerx Pharma Announces FDA Safe to Proceed Letter for Investigational New Drug Application for its αVβ3 Small Molecule-Drug Conjugate (SMDC) VIP236

By Benzinga Newsdesk

December 13, 10:29 AM

VIP236 is a first-in-class αVβ3 integrin binder SMDC with the potential to address a broad patient population across multiple solid tumor indications Preclinical studies with VIP236 demonstrated

VINC