- Spark Newswire

2 minute read

Rhythm Pharmaceuticals’ Shares Dive Following FDA’s Verdict On IMCIVREE Drug

Today, 8:00 PM

The U.S. Food and Drug Administration (FDA) has approved Rhythm Pharmaceuticals’ (NASDAQ: RYTM) supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for patients with Bardet-Biedl syndrome (BBS).

RYTM

1 minute read

Plus Therapeutics Concludes Enrolment In Initial-Stage Study Of Cerebrospinal Fluid Cancer Setting

By Ragothaman Srinivasan

Today, 8:00 PM

Plus Therapeutics (NASDAQ: PSTV) has concluded patient enrolment in the first cohort of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of Rhenium-186 NanoLiposome (186RNL) for the treatment of leptomeningeal metastases (LM).

PSTV

1 minute read

Kintara Therapeutics’ Stock Shooting Higher As FDA Grants Fast Track Designation To Brain Cancer Drug

By Ragothaman Srinivasan

Today, 8:00 PM

The United States Food and Drug Administration (FDA) has granted Fast Track Designation to Kintara Therapeutics’ (NASDAQ: KTRA) lead drug candidate VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM).

KTRA

2 minute read

Bluebird Bio Secures FDA Advisory Committee’s Endorsement For Neurodegenerative Disease Drug

By Ragothaman Srinivasan

Today, 8:00 PM

The U.S.

BLUE

1 minute read

BioCryst Gets FDA Fast Track Designation For Bone Formation Disorder Candidate

By Ragothaman Srinivasan

Today, 8:00 PM

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BioCryst Pharmaceuticals's (NASDAQ: BCRX) lead drug candidate BCX9250 for the prevention of heterotopic ossification (HO) in patients with fibrodysplasia ossificans progressiva (FOP).

BCRX

1 minute read

DBV Technologies’ Shares Shoot Higher As Positive Results From Late-Stage Study Of Peanut Allergy In Toddlers Met Primary Endpoint

By Ragothaman Srinivasan

Today, 8:00 PM

DBV Technologies (NASDAQ: DBVT) announced positive topline results from EPITOPE study of its drug candidate Viaskin Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years.

DBVT

1 minute read

Novavax Shares Gain Following FDA Advisory Committee’s Positive Vote On Emergency Use Authorization (EUA) For COVID-19 Vaccine

By Ragothaman Srinivasan

Today, 8:00 PM

Novavax’s (NASDAQ: NVAX) COVID-19 vaccine (NVX-CoV2373) receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee (VRBPAC), recommending FDA to grant Emergency Use Authorization (EUA) for individuals aged 18 years and over.

NVAX

1 minute read

U.S. FDA Approves Regeneron And Sanofi’s Lead Drug For Skin Inflammation In Children

By Ragothaman Srinivasan

Today, 8:00 PM

The U.S.

REGN

1 minute read

Apellis Begins Paitent Dosing In Late-Stage Study Of Rare Kidney Disease Candidate

By Ragothaman Srinivasan

Today, 8:00 PM

Apellis Pharmaceuticals (NASDAQ: APLS) has dosed first patient in the VALIANT Phase 3 clinical study of its drug candidate Pegcetacoplan for primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G), two rare and debilitating kidney diseases with similar underlyin

APLS

1 minute read

Moderna Commences Late-stage Study of Flu Vaccine Candidate

By Ragothaman Srinivasan

Today, 8:00 PM

Moderna, Inc. (NASDAQ: MRNA) today announced Initiation of Patient dosing in the phase 3 clinical study of its seasonal influenza vaccine candidate mRNA-1010 for patients with influenza.

MRNA