FDA Archives - Page 80 of 220

2 minute read

Applied Therapeutics’ Investigational Drug Shows Clinical Benefit In Rare Metabolic Disorder, Chalks Out FDA Submission Plans

April 24, 11:33 AM

Applied Therapeutics Inc (NASDAQ:APLT) announced results from the ACTION-Galactosemia Kids study of govorestat (AT-007) for galactosemia, a rare genetic metabolic disease…

APLT

1 minute read

More Trouble For Foghorn Therapeutics: After Blood Cancer Trial, FDA Puts Another Cancer Trial On Clinical Hold

By Vandana Singh

April 24, 11:28 AM

The FDA has put Foghorn Therapeutics Inc’s (NASDAQ:FHTX) study on partial hold after a patient had a severe heart-related safety event.…

FHTX

2 minute read

Citius Pharmaceuticals Advances Mino-Lok Phase 3 Trial Achieving 85 Of 92 Events To Date

By Happy Mohamed

April 24, 9:11 AM

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care

CTXR

4 minute read

Lexaria Awards CRO Contract For Upcoming U.S. Phase 1b Hypertension Study

By Happy Mohamed

April 24, 9:05 AM

Clinical study will evaluate safety and tolerability of Lexaria's patented DehydraTECH-CBD as a potential treatment for hypertension California-based InClin to provide CRO services to manage and expedite the

LEXX

3 minute read

FDA Approves Medtronic’s MiniMed 780g System

By Happy Mohamed

April 21, 3:19 PM

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

MDT

1 minute read

Avanos Medical Recalls Certain BALLARD ACCESS Closed Suction Systems For Pediatric Use Citing Ventilation Risk

By Vandana Singh

April 21, 11:31 AM

Avanos Medical Inc (NYSE:AVNS) is recalling the Avanos BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold or Elbow Manifold (labeled…

AVNS

4 minute read

LianBio Announces China National Medical Products Administration Acceptance With Priority Review Of New Drug Application For Mavacamten For The Treatment Of Patients With Obstructive Hypertrophic Cardiomyopathy

By Happy Mohamed

April 21, 8:06 AM

LianBio (NASDAQ:LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced that China's National Medical Products Administration

LIAN

3 minute read

Janux Therapeutics Announces First Patient Dosed With JANX008 In First-In-Human Phase 1 Clinical Trial In Patients With Solid Tumors

By Happy Mohamed

April 20, 4:03 PM

Janux Therapeutics, Inc. (NASDAQ:JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell

JANX

1 minute read

DBV Technologies Outlines Regulatory Path For Viaskin Peanut Allergy Patch For Kids Below 3 Years

By Vandana Singh

April 20, 12:26 PM

DBV Technologies (NASDAQ: DBVT) received written responses from the FDA on the regulatory path for the investigational Viaskin Peanut 250 μg patch (DBV712) in toddlers ages 1 – 3 years old with a confirmed peanut allergy.

DBVT

4 minute read

Incyte Announces European Commission Approval Of Opzelura Cream For The Treatment Of Non-Segmental Vitiligo With Facial Involvement In Adults And Adolescents

By Benzinga Newsdesk

April 20, 10:22 AM

Opzelura® (ruxolitinib) Cream is the first approved treatment in the European Union (EU) to address repigmentation in non-segmental vitiligoPhase 3 data supporting the approval show treatment with Opzelura resulted

INCY