FDA Archives - Page 184 of 220

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Moleculin Receives FDA Orphan Drug Designation Of WP1122 For The Treatment Of Glioblastoma Multiforme

September 6, 8:46 AM

- Glioblastoma is the most aggressive malignant primary brain tumor with serious unmet medical need HOUSTON, Sept. 6, 2022 /PRNewswire/ -- Moleculin Biotech, Inc., (NASDAQ:MBRX)

MBRX

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FDA And Health Canada Clear IND For FSD Pharma To Proceed With Phase 2 Trial Of FSD201 For Nociplastic Pain Associated With Idiopathic Mast Cell Activation Syndrome

By Bill Haddad

September 6, 8:32 AM

FSD Pharma Inc. (NASDAQ:HUGE) (CSE:HUGE) (FRE: 0K9A) (“FSD Pharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to

CSE:HUGE

2 minute read

Hoth Therapeutics mRNA Frame-Shifting Therapeutic, HT-004, Shows Potential To Reduce Lung Inflammation In Asthma And Allergy Disorders

By Benzinga Newsdesk

September 6, 8:22 AM

Treatment with HT-004 significantly reduced lung inflammation after ovalalbumin (OVA) challenge in an asthma and allergy mouse model NEW YORK, Sept. 6, 2022 /PRNewswire/ -- Hoth Therapeutics, Inc.

HOTH

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Spero Therapeutics Provides Tebipenem HBr Program Update Following Type A Meeting With FDA; Announces ‘Alignment with the FDA on a regulatory path forward for the continued development of tebipenem Hbr’

By Bill Haddad

September 6, 8:10 AM

Alignment with the FDA on a regulatory path forward for the continued development of tebipenem Hbr FDA feedback indicates positive results from a single additional Phase 3 clinical trial in patients with

SPRO

2 minute read

FDA
News

Soligenix Announces FDA Awards $2.6M Orphan Products Development Grant For Expanded Study Of HyBryte In The Treatment Of Cutaneous T-Cell Lymphoma

By Bill Haddad

September 6, 7:31 AM

Grant supports study of expanded HyBryte™ treatment, including in the Home Use Setting PRINCETON, N.J., Sept. 6, 2022 /PRNewswire/ -- Soligenix, Inc. (NASDAQ:SNGX) (Soligenix or the Company), a late-stage

SNGX

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Dyne Therapeutics Announces First Patient Dosed In Phase 1/2 DELIVER Clinical Trial Of DYNE-251 For The Treatment Of Duchenne Muscular Dystrophy

By Bill Haddad

September 6, 7:13 AM

Data from Global, Multiple Ascending Dose DELIVER Trial Anticipated in the Second Half of 2023 - - Dyne to Host “Spotlight on the Clinic” Virtual Event on September 12 - WALTHAM, Mass., Sept. 06, 2022

DYN

4 minute read

Ironwood Pharmaceuticals Reports Positive Topline Data From Phase III Trial Of LINZESS (linaclotide) In Pediatric Patients Aged 6-17 With Functional Constipation; Study Met Primary And Secondary Endpoints

By Bill Haddad

September 6, 7:04 AM

– Study met primary and secondary endpoints – – Results add to body of data supporting the safety of linaclotide for this patient population – – There are currently no FDA approved

IRWD

1 minute read

SINOVAC Approved to Initiate Clinical Trial for Its Omicron Containing COVID-19 Vaccine in Chile

By Bill Haddad

September 6, 6:01 AM

Sinovac Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ:SVA), a leading provider of biopharmaceutical products in China, announced that the Chilean Public Health Institute (Instituto de Salud

SVA