Biotech Archives - Page 707 of 733

1 minute read

Eledon Secures FDA Clearance For Kidney Transplant Rejection Study

August 1, 7:34 AM

The U.S. Food and Drug Administration (FDA) has cleared the Eledon Pharmaceuticals’ (NASDAQ: ELDN) Investigational New Drug (IND) application to evaluate Tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

ELDN

1 minute read

Beam Therapeutics Announces FDA Clinical Hold On BEAM-201 IND Application

By Benzinga Newsdesk

August 1, 6:30 AM

Beam Therapeutics Inc. (NASDAQ:BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that on Friday, July 29, 2022, the company was informed via e-mail communication

BEAM

1 minute read

FDA Removes Clinical Hold On Celyad’s Colorectal Cancer Trial

By Vandana Singh

August 1, 5:54 AM

The FDA has lifted the clinical hold on Celyad Oncology SA’s (NASDAQ:CYAD) CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the company made changes…

CYAD

4 minute read

Biotech Investors: August’s Key PDUFA Catalysts You Must Know

By Shanthi Rexaline

July 31, 9:21 AM

Regulatory decisions have yet to pick up pace this year. July’s calendar was light, but the good news was that most decisions turned out to be positive. That said, none of the drugs approved during the month were new molecular entities, underlining a lack of innovation going on in the sector.

ACAD

2 minute read

Bill Gates, Jeff Bezos Unite To ‘Change The Course’ Of Neurological Disorder Impacting 6.5 Million Americans

By Shanthi Rexaline

July 30, 4:04 PM

It’s a well-known fact that Microsoft Corporation (NASDAQ: MSFT) co-founder Bill Gates, through his Bill & Melinda Gates Foundation, is working toward eliminating infectious diseases and eradicating poverty in developing and under-developed countries.

AMZN

3 minute read

Recap Of Friday’s Biotech Catalysts – End of The Day Summary

By Ragothaman Srinivasan

July 29, 5:24 PM

The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ (NASDAQ:ARQT) New Drug Application (NDA) for ZORYVE…

ABBV

1 minute read

Arcutis Gets FDA Nod For Plaque Psoriasis Candidate, Sees Commercial Launch In Mid-August

By Ragothaman Srinivasan

July 29, 4:36 PM

The U.S. Food and Drug Administration (FDA) has approved Arcutis Biotherapeutics’ (NASDAQ: ARQT) New Drug Application (NDA) for ZORYVE (roflumilast) cream 0.3% for the treatment of plaque psoriasis in patients 12 years of age or older.

ARQT