Biotech Archives - Page 762 of 795

5 minute read

FDA
News

FDA Approves Arcutis’ ZORYVE™ (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older

July 29, 4:07 PM

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, announced today that the U.S. Food and Drug

ARQT

1 minute read

FDA Says Cdc Has Non-Variola Orthopoxvirus Test That Detects Monkeypox By Swab From Monkeypox Lesion Which At This Time Is The Only FDA-Cleared Test

By Bill Haddad

July 29, 2:53 PM

-Reuters

SIGA

1 minute read

FDA Says Currently No Human Data Demonstrating The Efficacy Of Tpoxx For The Treatment Of Monkeypox

By Bill Haddad

July 29, 2:51 PM

-Reuters

SIGA

1 minute read

Watching Monkeypox-Related Stocks After FDA Provides Update On Agency Response To Monkeypox Outbreak; FDA Says Important To Note That Already Have An FDA-Approved Vaccine For The Prevention Of Monkeypox Disease And An FDA-Cleared Diagnostic Test

By Bill Haddad

July 29, 2:47 PM

-Reuters

AEMD

1 minute read

Duchenne Gene Therapy Firm Sarepta Therapeutics’ Earns 8% Price Target Hike From This Analyst

By Vandana Singh

July 29, 1:53 PM

Earlier today, Sarepta Therapeutics Inc (NASDAQ:SRPT) announced that it would submit the marketing application and seek accelerated FDA approval for SRP-9001 in…

SRPT

1 minute read

AstraZeneca Drops Moderna-Partnered, Phase 2 Heart Disease Drug Candidate

By Vandana Singh

July 29, 1:46 PM

AstraZeneca Plc (NASDAQ: AZN) has removed a Moderna Inc (NASDAQ: MRNA)-partnered cardiovascular disease candidate from its phase 2 pipeline.

AZN

1 minute read

Novo Nordisk Once-Weekly Insulin Hits Primary Goals In In Two Phase 3 Trials

By Vandana Singh

July 29, 1:42 PM

Novo Nordisk A/S (NYSE:NVO) announced headline results from the ONWARDS 3 and ONWARDS 4 Phase 3a trials with once-weekly insulin icodec…

NVO

1 minute read

FDA
News

Novavax Requests Expanded Emergency Use Listing With World Health Organization For Nuvaxovid Covid-19 Vaccine For Adolescents Aged 12 Through 17

By Benzinga Newsdesk

July 29, 12:09 PM

Request Based On Data From Ongoing Pediatric Expansion Of Phase 3 Prevent-19 Trial Of 2,247 Adolescents Aged 12 Through 17 Years

NVAX

1 minute read

Enanta Shares Rise On Positive Data From Initial-Stage Covid Study

By Ragothaman Srinivasan

July 29, 11:32 AM

Enanta Pharmaceuticals (NASDAQ: ENTA) reported positive topline data from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of orally administered single and multiple ascending doses of EDP-235 in healthy adult subjects.

ENTA

1 minute read

Omeros Shares Climb As FDA Grants Orphan Drug Status To Blood Disorder Candidate

By Ragothaman Srinivasan

July 29, 10:06 AM

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Omeros Corporation’s (NASDAQ: OMER) lead asset OMS906 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

OMER