Biotech Archives - Page 760 of 795

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SCYNEXIS Shares Climb As FDA Accepts Filing For Vaginal Yeast Infection Candidate Under Priority Review

August 1, 12:01 PM

SCYNEXIS (NASDAQ: SCYX) announced that the U.S. Food and Drug Administration (FDA) has accepted its submission of a supplemental New Drug Application (sNDA) to expand the label of BREXAFEMME (ibrexafungerp tablets) to include the prevention of recurrent vulvovaginal candidiasis (RVVC).

SCYX

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FDA Accepts Gamida’s Filing For Stem Cell Transplant Candidate Under Priority Review

By Ragothaman Srinivasan

August 1, 11:43 AM

The U.S. Food and Drug Administration (FDA) has accepted for filing the Gamida Cell’s (NASDAQ: GMDA) Biologics License Application (BLA) for omidubicel in the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant.

GMDA

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Immutep’s Lung Cancer Candidate Shows Encouraging Efficacy As Second-Line Treatment

By Vandana Singh

August 1, 11:18 AM

Immutep Limited (NASDAQ:IMMP) announced new interim data from 2nd line non-small cell lung cancer (NSCLC) patients (Part B) in the Phase…

IMMP

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Avalo Therapeutics, Apollo Therapeutics Ink Pact For Anti-IL-18 Antibody

By Vandana Singh

August 1, 11:09 AM

Avalo Therapeutics Inc (NASDAQ:AVTX) and Apollo Therapeutics Group Limited have entered into a worldwide, exclusive license agreement granting rights to Apollo to research,…

AVTX

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FDA
News

Scisparc Signs Clinical Trial Agreement With Yale University To Conduct Its Phase IIB Trial In Tourette Syndrome

By Benzinga Newsdesk

August 1, 9:30 AM

SciSparc Ltd. (NASDAQ:SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system,

SPRC

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Krystal Biotech Gets FDA Nod For Initial-Stage Lung Infection Study

By Ragothaman Srinivasan

August 1, 9:10 AM

The United States Food and Drug Administration (FDA) has accepted Krystal Biotech’ (NASDAQ: KRYS) Investigational New Drug (IND) application to evaluate KB407 in a clinical trial for cystic fibrosis (CF).

KRYS

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AstraZeneca Cuts Innate-Partnered Phase 3 Trial In Head & Neck Cancer

By Vandana Singh

August 1, 8:48 AM

Innate Pharma SA’s (NASDAQ:IPHA) futility interim analysis of the INTERLINK-1 Phase 3 study sponsored by AstraZeneca Plc (NASDAQ:AZN) did not meet a…

AZN

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FDA
News

Evofem Announces Completion of Last Subject Last Visit (LSLV) In Registrational Phase 3 “EVOGUARD” Trial Evaluating Phexxi For Prevention Of Chlamydia And Gonorrhea In Women

By Benzinga Newsdesk

August 1, 8:48 AM

-- Top-line readout of data expected in October 2022 -- -- U.S. regulatory submission planned for the first half of 2023 --

EVFM

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Akari Therapeutics To Reallocate Cash And Resources To Phase 3 Trial On Nomacopan In HSCT-TMA And To Pre-Clinical Program Of PAS-Nomacopan In GA; Will Discontinue Clinical Program Evaluating Nomacopan In Bullous Pemphigoid, Says Is Not Reducing Headcou…

By Bill Haddad

August 1, 8:18 AM

Akari Therapeutics, Plc (NASDAQ:AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that it is prioritizing two pipeline programs. Cash and

AKTX

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Armata Pharmaceuticals Announces Clearance Of IND For Prosthetic Joint Infections

By Benzinga Newsdesk

August 1, 8:04 AM

Second indication for AP-SA02 which targets Staphylococcus aureus including MRSA Potential to significantly improve PJI patient outcomes Expands Armata's pursuit of phage therapy as a solution for

ARMP