- Spark Newswire

1 minute read

FDA Accepts MediWound’s Refiling For Severe Thermal Burns Therapy For Review

Today, 11:41 AM

The U.S. Food and Drug Administration (FDA) has accepted for review MediWound’s (NASDAQ: MDWD) recently re-submitted Biologics License Application (BLA) for its lead asset NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.

MDWD

2 minute read

Recap Of Tuesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 11:41 AM

Avalo Therapeutics (NASDAQ:AVTX) has dosed the first patient in the pivotal LADDER trial to assess the efficacy and…

AVTX

4 minute read

Recap Of Monday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 11:41 AM

The U.S. Food and Drug Administration (FDA) has cleared the Eledon Pharmaceuticals’ (NASDAQ:ELDN) Investigational New Drug (IND) application…

AERI

1 minute read

Aerie Shares Gain Following Patient Dosing In Late-Stage Dry Eye Disease Study

By Ragothaman Srinivasan

Today, 11:41 AM

Aerie Pharmaceuticals (NASDAQ: AERI) has initiated patient dosing in the Phase 3 registrational COMET-3 study to evaluate AR-15512 ophthalmic solution as a treatment for the signs and symptoms of dry eye disease (DED).

AERI

1 minute read

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

By Ragothaman Srinivasan

Today, 11:41 AM

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

1 minute read

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

By Ragothaman Srinivasan

Today, 11:41 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

1 minute read

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

By Ragothaman Srinivasan

Today, 11:41 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

1 minute read

Eledon Secures FDA Clearance For Kidney Transplant Rejection Study

By Ragothaman Srinivasan

Today, 11:41 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

3 minute read

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

By Ragothaman Srinivasan

Today, 11:41 AM

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

Today, 11:41 AM

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