FDA - Spark Newswire

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FDA
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Earlier, Sanofi Announced FDA Approved Once-Weekly Altuviiio, New Class of Factor VIII Therapy For Hemophilia A That Offers Significant Bleed Protection

Today, 9:36 PM

The U.S. Food and Drug Administration (FDA) has approved ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referred to as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy.The U.S.

SNY

1 minute read

4D Molecular Discloses Updated Data From Currently Paused Fabry Disease Cardiomyopathy Study

By Vandana Singh

Today, 9:36 PM

4D Molecular Therapeutics Inc (NASDAQ:FDMT) announced updated interim safety and efficacy data from the two 4D-310 INGLAXA Phase 1/2 trials for…

FDMT

6 minute read

Sangamo Therapeutics Announces Evidence Of Clinical Benefit In Phase 1/2 STAAR Study In Fabry Disease

By Happy Mohamed

Today, 9:36 PM

- Sustained, elevated expression of alpha-galactosidase A (α-Gal A) activity observed in 13 patients for over two years for the longest treated patient as of cutoff

SGMO

3 minute read

Additional Interim Data From Phase I/II/III CAMPSIITE Trial Of REGENXBIO’s RGX-121 For The Treatment Of MPS II (Hunter Syndrome) Presented At 19th Annual WORLDSymposium

By Happy Mohamed

Today, 9:36 PM

RGX-121, a potential one-time gene therapy for the treatment of MPS II, continues to be well-tolerated with no drug-related SAEs across three dose levels Additional data from patients in Cohort 3 using pivotal program

RGNX

3 minute read

Gilead Presents Proof-Of-Concept Data For Investigational Combination Regimen Of Lenacapavir With Broadly Neutralizing Antibodies As A Potential Twice-Yearly Approach For The Treatment Of HIV

By Happy Mohamed

Today, 9:36 PM

– Study Demonstrates the Potential of Lenacapavir in Combination with Broadly Neutralizing HIV Antibodies Teropavimab and Zinlirvimab – – Findings Support Further Evaluation of the Investigational

GILD

1 minute read

ProPhase Labs Announces Plans To Initiate Clinical Trial Of Equivir, Goal To Launch Commercially In Q4 2023

By Happy Mohamed

Today, 9:36 PM

ProPhase Labs, Inc. (NASDAQ:PRPH) ("ProPhase"), a growth oriented and diversified diagnostics, genomics and biotech company, today announced that its wholly-owned subsidiary, ProPhase BioPharma, Inc. (PBIO), is

PRPH

6 minute read

Psyched: Four New States With Reform Bills, Psilocybin For Genetic Disorders And Functional Neurological Disorder, Struggle For Access & More

By Lara Goldstein

Today, 9:36 PM

Psychedelics States Reform: Utah, Iowa, Missouri and Oklahoma’s New Bills; Hawaii, Arizona and Washington's Green Lights, New Hampshire's Setback Earlier this week, three bills were introduced and added to the list of measures calling for some sort of psychedelics legalization, while some of the already filed ones continue progressing and others get a thumbs down.

AGNPF

1 minute read

Windtree Therapeutics Has Been Granted U.S. Patent Number 11,583,540 Titled “Istaroxime-Containing Intravenous Formulation For The Treatment Of Acute Heart Failure”

By Happy Mohamed

Today, 9:36 PM

https://ppubs.uspto.gov/pubwebapp/external.html?q=(11583540).pn

WINT

1 minute read

Why Chemomab Therapeutics Shares Are Trading Higher Today

By Ye Kuang

Today, 9:36 PM

Chemomab Therapeutics Ltd (NASDAQ: CMMB) shares are trading higher on Tuesday after the company announced FDA clearance of its Investigational New Drug Application to evaluate CM-101 in a Phase 2 trial in

CMMB

1 minute read

FDA Gives Green Signal To Chemomab Therapeutics’ Rare Disease Study

By Vandana Singh

Today, 9:36 PM

The FDA has signed off Chemomab Therapeutics Ltd’s (NASDAQ:CMMB) Investigational New Drug (IND) Application to evaluate CM-101 in a Phase 2…

CMMB