FDA Archives - Page 206 of 220

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FDA
News

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

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

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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

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FDA
News

FDA Grants Orphan Drug Designation to Omeros’ MASP-3 Inhibitor OMS906 For Treatment Of Paroxysmal Nocturnal Hemoglobinuria

By Benzinga Newsdesk

July 29, 8:45 AM

Omeros Corporation today announced that OMS906 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). OMS906 targets

OMER

2 minute read

Adamis Pharmaceuticals Provides Update On Clinical Study Assessing Tempol For The Treatment Of COVID-19

By Benzinga Newsdesk

July 29, 7:31 AM

Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today provided an update on the Company's ongoing U.S. Phase 2/3 clinical trial to evaluate the safety and efficacy of Tempol as a treatment for COVID-19. The

ADMP

2 minute read

Bausch Health To Appeal Expected Court Decision On Xifaxan Patents

By Vandana Singh

July 29, 5:01 AM

Yesterday, Bausch Health Companies Inc (NYSE: BHC) stock closed 50% lower after the reports on the order on patent litigation over Xifaxan (rifaximin).

BHC

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FDA
News

ImmunityBio Announces FDA Acceptance Of Biologics License Application For N-803 In BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma In Situ

By Benzinga Newsdesk

July 28, 4:54 PM

The FDA accepted for review a Biologics License Application (BLA) from ImmunityBio, Inc. ((IBRX), for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder

IBRX

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FDA
News

U.S. Health And Human Services Secretary Becerra Says Monkeypox Testing Now 60,000 To 80,000 Per Week

By Benzinga Newsdesk

July 28, 11:25 AM

-Reuters

AEMD

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FDA
News

Theratechnologies Highlights Trogarzo Data At AIDS 2022; Co Says Data Shows Potential for Improved Treatment Regimens

By Benzinga Newsdesk

July 28, 11:21 AM

New sub-analysis on Trogarzo clinical trial patients demonstrates that long-term viral suppression is not influenced by partially active agents. Predictive pharmacokinetic modelling shows that new methods of

THTX

3 minute read

Daily Biotech Pulse: GSK’s Kidney Disease Drug Approved For Children, Tonix Pharma To Launch Monkeypox Vaccine Study In Kenya, Positive Effect Of Cyclerion’s Schizophrenia Candidate

By Vandana Singh

July 28, 10:37 AM

Here's a roundup of top developments in the biotech space over the last 24 hours:

ABBV

2 minute read

Atossa Therapeutics Announces Dosing Completed In Part C of Atossa’s Phase 1/2a Study Of AT-H201 In Healthy Volunteers

By Benzinga Newsdesk

July 28, 9:05 AM

Atossa Therapeutics, Inc. (NASDAQ:ATOS) a clinical stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases with a current

ATOS