FDA - Spark Newswire

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FDA
News

ORIC Pharmaceuticals Announces FDA Clearance Of IND Application For ORIC-533, A Highly Potent, Orally Bioavailable Small Molecule CD73 Inhibitor

Today, 3:12 PM

ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that the U.S. Food and Drug Administration

ORIC

1 minute read

Orphazyme To Cut Two-Third Workforce Under Restructuring; Reaffirms FY21 Outlook

By Vandana Singh

Today, 3:12 PM

ORPH

1 minute read

Intellia Shares Shoot Higher On Promising Biomarker Data From CRISPR/Cas9 Genome Editing Candidate

By Vandana Singh

Today, 3:12 PM

Intellia Therapeutics Inc (NASDAQ:NTLA) and Regeneron Pharmaceuticals Inc (NASDAQ:REGN) have announced positive interim data from an ongoing Phase 1 study of NTLA-2001, which…

NTLA

2 minute read

Regeneron’s and Sanofi’s Dupixent SmPC Updated With Long-term Data Reinforcing Well-established Safety Profile in Adults With Moderate-to-severe Atopic Dermatitis

By Charles Gross

Today, 3:12 PM

Long-term safety data from a study of adults with moderate-to-severe atopic dermatitis treated with Dupixent will be added to the Dupixent Summary of Product Characteristics (SmPC) following a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use.

REGN

4 minute read

The Week Ahead In Biotech: Mediwound, Provention FDA Decisions, IPOs, Pending Clinical Readouts In Focus

By Shanthi Rexaline

Today, 3:12 PM

Biotech stocks reversed course and closed the week ended June 25 higher, thanks to the positive broader market sentiment.

AFMD

1 minute read

FDA
News

Clovis Oncology Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE) Posted to Clinical Trials Website on Friday; Study is Recruiting

By Charles Gross

Today, 3:12 PM

https://clinicaltrials.gov/ct2/show/NCT04939246

CLVS

1 minute read

FDA
News

Viewray Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction Posted to Clinical Trials Website on Friday; Study is Not Yet Recruiting

By Charles Gross

Today, 3:12 PM

https://clinicaltrials.gov/ct2/show/NCT04939246

VRAY

1 minute read

FDA
News

US Pauses Distribution Of Eli Lilly’s COVID-19 Antibody Therapies, Co. Says Bamlanivimab, Etesevimab Administered Together Do Not Retain Neutralization Effects Against Gamma, Beta Variant Of SARS-CoV-2

By Benzinga Newsdesk

Today, 3:12 PM

-Reuters-Reuters

LLY

1 minute read

AstraZeneca’s Type 2 Diabetes Treatment Shows Clinical Benefit In Adolescents

By Vandana Singh

Today, 3:12 PM

AstraZeneca Plc (NASDAQ:AZN) has reported results from the Phase 3 trial evaluating exenatide extended-release 2mg in adolescents aged 10–17 years with…

AZN

1 minute read

FDA To Miss Action Dates For AbbVie’s Upadacitinib Application For Psoriatic Arthritis, Ankylosing Spondylitis

By Vandana Singh

Today, 3:12 PM

The FDA will not meet action dates for AbbVie Inc’s (NYSE:ABBV) supplemental marketing applications for Rinvoq (upadacitinib) for active psoriatic arthritis and…

ABBV