Ragothaman Srinivasan - Spark Newswire

1 minute read

ReShape Lifesciences Shares Soar As FDA Announced Clearance To GIBI HD Calibration Tubes In Weight Loss Procedures

Today, 9:47 AM

The U.S. Food and Drug Administration (FDA) has announced 510(k) clearance to ReShape Lifesciences’ (NASDAQ: RSLS) Gastro Intestinal Balloon Indicator (GIBI HD) calibration tube for use in gastric and bariatric surgical procedures.

RSLS

1 minute read

Lexaria Gets FDA’s Positive Feedback On Pre-Clinical Trial Of Hypertension Candidate

By Ragothaman Srinivasan

Today, 9:47 AM

Lexaria Bioscience Corp. (NASDAQ: LEXX) announced that it has received a positive full written response from the Food and Drug Administration (FDA) from its pre-Investigational New Drug meeting regarding DehydraTECH-CBD for the treatment of hypertension.

LEXX

3 minute read

Recap of Tuesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 9:47 AM

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ (NASDAQ:RLMD) lead asset…

BGNE

1 minute read

NeuroOne Seeks Again FDA Clearance For sEEG Electrode In Brain Mapping Diagnostics

By Ragothaman Srinivasan

Today, 9:47 AM

NeuroOne Medical Technologies (NASDAQ: NMTC) has submitted a special 510(k) to the U.S. Food and Drug Administration (FDA) for its sEEG electrode to extend the duration of use from less than 24 hours to less than 30 day use.

NMTC

3 minute read

Recap Of Thursday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 9:47 AM

ARQT

1 minute read

Marker Therapeutics Shares Jump 60 Percent As FDA Announced Clearance To Blood Cell Cancer Study

By Ragothaman Srinivasan

Today, 9:47 AM

The U.S. Food and Drug Administration (FDA) announced clearance to Marker Therapeutics’ (NASDAQ: MRKR) Investigational New Drug (IND) application for MT-601 for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma.

MRKR

1 minute read

Rain Therapeutics Concludes Enrolment In Late-Stage Tissue Cancer Study, Expects Topline Data In H1 2023

By Ragothaman Srinivasan

Today, 9:47 AM

Rain Therapeutics (NASDAQ: RAIN) has completed patient enrolment in its Phase 3 MANTRA trial of its lead asset, milademetan for well-differentiated / dedifferentiated (WD/DD) liposarcoma (LPS).

RAIN

1 minute read

Astria Therapeutics Commences Initial-Stage Skin Disorder Study, Sees Preliminary Data By Year-end

By Ragothaman Srinivasan

Today, 9:47 AM

Astria Therapeutics (NASDAQ: ATXS) announced initiation of a Phase 1a clinical trial of STAR-0215 in healthy subjects. STAR-0215 is designed to provide long-acting, effective attack prevention for hereditary angioedema (HAE), with dosing once every three months or longer.

ATXS

3 minute read

Recap Of Wednesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 9:47 AM

The U.S. Food and Drug Administration (FDA) has accepted for review MediWound’s (NASDAQ:MDWD) recently re-submitted Biologics License Application…

ALNY

2 minute read

Alnylam Shares Shoot Higher Following Positive Clinical Results From Late-Stage ATTR Amyloidosis Therapeutics

By Ragothaman Srinivasan

Today, 9:47 AM

Alnylam (NASDAQ: ALNY) announced positive results from the APOLLO-B Phase 3 study of Patisiran for the treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.

ALNY