Biotech Archives - Page 761 of 795

1 minute read

Aileron Therapeutics Outlines Strategy To Strengthen Phase 1b Clinical Trial Of ALRN-6924 In Patients With p53-Mutated Breast Cancer

August 1, 7:52 AM

Enhancements to protocol, informed by recent ALRN-6924 data, are designed to improve the opportunity to demonstrate protection against chemotherapy-induced severe neutropenia, alopecia (hair loss) and potentially other toxicities in patients with p53-mutated breast cancer

ALRN

1 minute read

Eledon Secures FDA Clearance For Kidney Transplant Rejection Study

By Ragothaman Srinivasan

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

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Celyad Oncology Announced FDA Lifted Clinical Hold of CYAD-101-002 Phase 1b Trial

By Charles Gross

August 1, 5:47 AM

Celyad Oncology SA (Brussels:CYAD) (Paris:CYAD) (NASDAQ: CYAD) (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that the U.S.

CYAD

2 minute read

Eledon Pharmaceuticals Received FDA Clearance of IND Application to Evaluate Tegoprubart for the Prevention of Rejection in Kidney Transplant Recipients

By Charles Gross

August 1, 5:14 AM

Eledon Pharmaceuticals, Inc. ("Eledon") (NASDAQ: ELDN), a patient-focused clinical stage biopharmaceutical company committed to the development of innovative and impactful treatments for organ and cell transplantation, autoimmune conditions, and neurodegenerative disease, today announced that the U.S.

ELDN

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