FDA Archives - Page 55 of 220

3 minute read

Panbela Announces Preliminary Safety Analysis For ASPIRE Trial; The DSMB Has Recommended That The Study Continue Without Modification

July 10, 8:17 AM

Panbela Therapeutics, Inc. (NASDAQ:PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, announces that the independent Data Safety

PBLA

2 minute read

Paratek Pharmaceuticals Announces Modification Of BARDA Contract To Advance The Development Of NUZYRA For Post-Exposure Prophylaxis And Treatment Of Pulmonary Anthrax

By Happy Mohamed

July 10, 8:04 AM

-- Third procurement to be split into two procurements based on the achievement of specific anthrax development milestones -- Next procurement expected in early 2024 BOSTON, July 10, 2023 (GLOBE NEWSWIRE)

PRTK

2 minute read

Analyst Holds Steady On Curis As FDA Removes Partial Clinical Hold On Leukemia Study

By Vandana Singh

July 7, 1:28 PM

Thursday, the FDA removed the partial clinical hold on Curis Inc's (NASDAQ: CRIS) TakeAim Leukemia Phase 1/2 study of emavusertib

CRIS

2 minute read

BrainStorm Cell Therapeutics Shares Fall After Updated Biomarker Data From Lead Cell Therapy Candidate

By Vandana Singh

July 7, 8:34 AM

BrainStorm Cell Therapeutics Inc (NASDAQ: BCLI) presented new biomarker data from the Phase 3 trial of its late-stage investigational amyotrophic lateral sclerosis (ALS) treatment, NurOwn, at the 2023 ALS and Related Motor Neuron Diseases

BCLI

1 minute read

What’s Going On With Biogen Stock Thursday

By Henry Khederian

July 6, 5:08 PM

Biogen Inc (NASDAQ: BIIB) shares were flat in Thursday's after-hours session after falling marginally by 0.31% to $284.99 during

BIIB

4 minute read

FDA Converts Novel Alzheimer’s Disease Treatment To Traditional Approval; Action Follows Confirmatory Trial To Verify Clinical Benefit

By Happy Mohamed

July 6, 4:48 PM

https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb),

BIIB

6 minute read

‘FDA Approves Alzheimer’s Drug Leqembi, Paving Way For Broader Medicare Coverage’ – CNBC

By Happy Mohamed

July 6, 4:47 PM

The FDA has approved Eisai and Biogen’s Alzheimer’s treatment Leqembi. Medicare has promised to begin covering Leqembi on the same day the FDA approves the antibody treatment. Medicare coverage is a

BIIB

2 minute read

Can Psychedelics Therapy Be Reimbursed? AMA Releases Details On Coding These Procedures

By Lara Goldstein

July 6, 1:47 PM

The American Medical Association (AMA) published language concerning the recently-approved Current Procedural Terminology (CPT) III codes applying to psychedelic-assisted therapies, as announced by its

CMPS

1 minute read

What’s Going On With Kazia Therapeutics Stock Today?

By Adam Eckert

July 6, 9:41 AM

Kazia Therapeutics Ltd (NASDAQ: KZIA) shares are trading higher Thursday after the company announced it received FDA Fast Track Designation for its

KZIA

3 minute read

Ultragenyx Announces First Patients Dosed In Phase 3 Program Evaluating Setrusumab For Treatment Of Osteogenesis Imperfecta

By Benzinga Newsdesk

July 6, 8:11 AM

Pivotal Phase 3 portion of Orbit study now enrolling approximately 195 pediatric and young adult patients Newly initiated Phase 3 Cosmic study now enrolling approximately 65 younger pediatric patients

MREO