- Spark Newswire

1 minute read

aTyr Pharma Gets FDA Fast Track Status For Systemic Sclerosis Candidate

Today, 6:02 AM

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for aTyr Pharma’s (NASDAQ: LIFE) lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc)-associated, interstitial lung disease (ILD).

LIFE

4 minute read

Important Biotech Catalysts For September 12, 2022 – End Of The Day Summary

By Ragothaman Srinivasan

Today, 6:02 AM

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Mersana Therapeutics’ (NASDAQ:MRSN) lead candidate…

ACAD

2 minute read

Adamis Achieves Enrolment Target In Mid-Stage Covid-19 Study, Awaits Data Safety Monitoring Board Review Later This Month

By Ragothaman Srinivasan

Today, 6:02 AM

Adamis Pharmaceuticals (NASDAQ: ADMP) announced that it has reached the initial planned enrollment target in the ongoing U.S. Phase 2/3 clinical trial investigating Tempol as a treatment for COVID-19.

ADMP

1 minute read

Agenus Begins Mid-Stage Global Studies On Colorectal And Skin Cancer Candidate

By Ragothaman Srinivasan

Today, 6:02 AM

Agenus (NASDAQ: AGEN) has initiated Phase 2 ACTIVATE trials of botensilimab to advance globally in metastatic patients who have progressed on available therapies. This global Phase 2 program include clinical trials of ACTIVATE-Colorectal and ACTIVATE-Melanoma studies.

AGEN

1 minute read

BioLineRx Seeks FDA Nod For Stem Cell Mobilization Candidate

By Ragothaman Srinivasan

Today, 6:02 AM

BioLineRx (NASDAQ: BLRX) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate Motixafortide in stem cell mobilization (SCM) for autologous bone marrow transplantation for multiple myeloma patients.

BLRX

1 minute read

U.S. FDA Accepts Acadia’s Filing For Rett Syndrome Candidate Under Priority Review

By Ragothaman Srinivasan

Today, 6:02 AM

The U.S. Food and Drug Administration (FDA) has accepted for filing Acadia Pharmaceuticals’ (NASDAQ: ACAD) New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome. The regulatory agency has granted a priority review and assigned a PDUFA action date of March 12, 2023.

ACAD

1 minute read

Mersana Shares Climb As FDA Grants Fast Track Status To Triple-Negative Breast Cancer Candidate

By Ragothaman Srinivasan

Today, 6:02 AM

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Mersana Therapeutics’ (NASDAQ: MRSN) lead candidate XMT-1660 for the treatment of adult patients with advanced or metastatic triple-negative breast cancer (TNBC).

MRSN

3 minute read

Important Biotech Catalysts For September 9, 2022 – End Of The Day Summary

By Ragothaman Srinivasan

Today, 6:02 AM

The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ (NASDAQ:SPPI) lead asset ROLVEDON (eflapegrastim-xnst) injection to…

ADAP

1 minute read

Spectrum Gets FDA Nod For Febrile Neutropenia Candidate, Sees Commercial Launch In Q4 2022

By Ragothaman Srinivasan

Today, 6:02 AM

The U.S. Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ (NASDAQ: SPPI) lead asset ROLVEDON (eflapegrastim-xnst) injection to decrease the incidence of infection, as manifested by febrile neutropenia.

SPPI

1 minute read

U.S. FDA And European Medicines Agency Accepted Pfizer’s Hair Loss Candidate Submission For Review

By Ragothaman Srinivasan

Today, 6:02 AM

The U.S. Food and Drug Administration (FDA) has accepted for review Pfizer’s (NYSE: PFE) New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The regulatory agency is expected to make a decision in the second-quarter of 2023.

PFE