FDA Archives - Page 69 of 220

1 minute read

FDA Approves First Oral Treatment For Crohn’s Disease, Making Seventh Approval For AbbVie’s Rinvoq

May 19, 8:13 AM

The FDA approved AbbVie Inc's (NASDAQ: ABBV) Rinvoq (upadacitinib) for moderately to severely active Crohn's disease patients with inadequate response or intolerance to

ABBV

2 minute read

Hologic Announces FDA Clearance Of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

By Happy Mohamed

May 19, 8:09 AM

Multiplexed Respiratory Test Now Available in the U.S. With New RespDirect Collection Kit Hologic Inc. (NASDAQ:HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the

HOLX

3 minute read

Satsuma Pharmaceuticals Announces FDA Acceptance Of 505(b)(2) NDA For STS101, A Novel And Investigational Dihydroergotamine Nasal Powder Product For The Acute Treatment Of Migraine

By Happy Mohamed

May 18, 4:03 PM

January 2024 PDUFA date expected If approved, STS101 would become the only DHE product evaluated in a randomized, placebo-controlled trial (the SUMMIT trial) against modern outcome measures recommended by both the

STSA

1 minute read

U.S. FDA Approves RINVOQ As A Once-Daily Pill For Moderately To Severely Active Crohn’s Disease In Adults

By Happy Mohamed

May 18, 12:27 PM

– The co-primary endpoints of endoscopic response (visible reduction of intestinal lining damage) and clinical remission were achieved by significantly more patients treated with RINVOQ (upadacitinib) at

ABBV

2 minute read

Processa Pharmaceuticals To Conduct Next Generation Chemotherapy-Capecitabine Phase 2 Trial Based On FDA Guidance And Project Optimus Oncology Initiative

By Happy Mohamed

May 18, 8:13 AM

Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company") today announces it has received guidance from the U.S. Food and Drug Administration ("FDA") regarding the

PCSA

2 minute read

Galera Announces FDA Orphan Drug Designation Granted To Rucosopasem For Pancreatic Cancer

By Benzinga Newsdesk

May 18, 8:07 AM

Galera Therapeutics, Inc. (NASDAQ: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that the U.S.

GRTX

1 minute read

Sientra’s Stock Soars: FDA Approves Its Portfinder Tech For Improved Usage In Plastic Surgery Procedures

By Vandana Singh

May 17, 2:39 PM

The FDA granted a 510(k) clearance to Sientra Inc's (NASDAQ: SIEN) Portfinder technology, an electronic handheld device that allows for the subcutaneous location of ports in Sientra's Dermaspan and

SIEN

1 minute read

Why Intercept Pharmaceuticals Shares Are Plunging Today

By Vandana Singh

May 17, 12:54 PM

Intercept Pharmaceuticals Inc (NASDAQ: ICPT) lost around 20% after the FDA issued briefing documents ahead of the adc

ICPT

1 minute read

FDA Eases Partial Hold On Avidity Biosciences’ Investigational Drug Study In Type Of Dystrophy

By Vandana Singh

May 17, 10:38 AM

The FDA has eased the partial clinical hold on Avidity Biosciences Inc's (NASDAQ: RNA) AOC 1001, allowing Avidity to double the number of participants in the MARINA Open-Label Extension (MARINA-OLE) study

RNA