FDA Archives - Page 54 of 220

2 minute read

Reported Earlier, Tandem Diabetes Care, Inc. Receives FDA Clearance For The Tandem Mobi Insulin Pump For People With Diabetes Age 6 And Up, Expanding The Company’s Portfolio Of Products

July 11, 12:50 PM

Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a leading insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance for the Tandem Mobi insulin pump for people with

TNDM

2 minute read

Why Are Adial Pharmaceuticals Shares Soaring Today

By Vandana Singh

July 11, 12:48 PM

Adial Pharmaceuticals Inc (NASDAQ: ADIL) shares are trading higher after the company provided a summary of feedback received following recent meetings with both U.S.

ADIL

1 minute read

Why Are Better Therapeutics Shares Gaining Today?

By Vandana Singh

July 11, 9:40 AM

Better Therapeutics Inc (NASDAQ: BTTX) shares are trading higher after the FDA approved the company's AspyreRx (formerly BT-001), a prescription-only digital treatment to provide cognitive behavioral therapy to adult patients

BTTX

2 minute read

Pulmatrix Announces Submission Of IND Application To FDA To Initiate A Phase 2 Trial Of Investigational Drug PUR3100 To Treat Acute Migraine

By Happy Mohamed

July 11, 9:06 AM

Pulmatrix, Inc. ("Pulmatrix" or the "Company") (NASDAQ:PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous

PULM

5 minute read

Adial Provides Business Update Following Favorable Comments From US And EU Regulatory Meetings

By Happy Mohamed

July 11, 8:43 AM

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL, ADILW)))) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of AD04, a genetically targeted, serotonin-3

ADIL

5 minute read

Better Therapeutics Receives FDA Authorization For AspyreRx To Treat Adults With Type 2 Diabetes; Demonstrated Clinically Meaningful And Statistically Significant Durable Reductions In A1c

By Happy Mohamed

July 10, 4:31 PM

First prescription digital behavioral therapeutic device delivering novel form of cognitive behavioral therapy via smartphone In a randomized controlled trial AspyreRx demonstrated clinically meaningful and

BTTX

2 minute read

Iovance’s Update Provides Reassurance With Upcoming Lifileucel’s FDA Action Date, Analyst Says

By Vandana Singh

July 10, 12:49 PM

Iovance Biotherapeutics Inc (NASDAQ: IOVA) announced regulatory and clinical updates related to its registrational single-arm Phase 2 IOV-LUN-202 trial in post-anti-PD-1

IOVA

1 minute read

Infinity Pharmaceuticals Says Second Proxy Advisory Firm Recommends Shareholders To Approve Proposed Merger

By Vandana Singh

July 10, 12:45 PM

Infinity Pharmaceuticals Inc (NASDAQ: INFI) announced further design features of its Phase 2 MARIO-8 study in Squamous Cell Cancer of the

INFI

3 minute read

Hillstream BioPharma Announces Strategic Reprioritization Of Pipeline To Targeting HER2/HER3 Solid Tumors Via Bispecific And ADC Antibodies And Biologics

By Happy Mohamed

July 10, 8:47 AM

Lead bispecific antibody, HSB-3215 designed to target novel conformational epitopes on high value validated targets, HER2 and HER3 Focus on optimizing ADCs to generate a more potent Bystander Effect and

HILS

3 minute read

Infinity Pharmaceuticals Provides Additional Information On MARIO-8 Study Evaluating Eganelisib In Combination With The PD-1 Targeted Checkpoint Inhibitor Pembrolizumab In Patients With Squamous Cell Cancer Of The Head And Neck

By Happy Mohamed

July 10, 8:31 AM

Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) ("Infinity"), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming drug candidate,

INFI