FDA Archives - Page 49 of 220

1 minute read

DBV Technologies Advances Peanut Allergy Program With FDA Support On Pediatric Studies

August 1, 9:29 AM

DBV Technologies (NASDAQ: DBVT) received Type C meeting written responses from the FDA on key study design elements for the COMFORT Toddlers and COMFORT Children supplemental safety studies in 1 – 3-year-olds and 4 – 7-year-olds,

DBVT

2 minute read

Jaguar Health Announces FDA Activation Of Third-Party Investigational New Drug Application For Evaluation Of Crofelemer For Treatment Of Uncontrolled Diarrhea In Patient With Short Bowel Syndrome

By Happy Mohamed

August 1, 8:49 AM

Napo Pharmaceuticals, a Jaguar Health company and the manufacturer of crofelemer, is supporting this physician-generated IND SAN FRANCISCO, CA / ACCESSWIRE / August 1, 2023 / Jaguar Health (NASDAQ:JAGX) ("the

JAGX

2 minute read

Immutep Receives Scientific Advice From European Medicines Agency

By Happy Mohamed

August 1, 8:21 AM

Immutep Limited ((ASX: IMM, NASDAQ:IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today

IMMP

2 minute read

scPharmaceuticals Announces Type C Meeting Feedback From FDA On Potential Heart Failure Class IV Indication Expansion

By Happy Mohamed

August 1, 8:13 AM

scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce

SCPH

3 minute read

Tyra Biosciences Announces FDA Orphan Drug Designation For TYRA-300 For The Treatment Of Achondroplasia

By Happy Mohamed

August 1, 8:11 AM

Tyra Biosciences, Inc. (NASDAQ:TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology,

TYRA

2 minute read

MSOs And Cannabis Rescheduling: A Safer Bet? Analyst Looks Closer At Pros And Cons

By Nicolas Jose Rodriguez

July 31, 6:14 PM

Will the rescheduling of cannabis fuel a boom in cannabis stocks? Analysts from Z&A delve into the pros and cons of MSOs and cannabis rescheduling in their latest equity research report.

CNBS

1 minute read

FDA
News

DBV Technologies Receives FDA Feedback On Design Elements For Viaskin Peanut Safety Studies; Expects To Seek Final Alignment With FDA On COMFORT Protocols Prior To Commencing Studies

By Benzinga Newsdesk

July 31, 4:27 PM

Received feedback from U.S. Food and Drug Administration (FDA) on DBV's two supplemental safety studies in toddlers (ages 1 – 3 years) and

DBVT

2 minute read

Software Update Leads To False Alarms In Baxter’s Spectrum Infusion Pumps, Urgent Correction Underway

By Vandana Singh

July 31, 12:57 PM

Baxter International Inc (NYSE: BAX) has

BAX

1 minute read

Why Citius Pharmaceuticals Stock Is Plunging Today?

By Vandana Singh

July 31, 9:55 AM

The FDA issued a Complete Response Letter regarding Citius Pharmaceuticals Inc's (NASDAQ: CTXR) Biologics License Application (BLA) seeking approval for denileukin diftitox (Lymphir), an engineered IL-2-diphtheria toxin fusion protein for relapsed or refractory cutaneous T-cell lymphoma (CTCL)

CTXR

4 minute read

GOP Rep. Blasts FDA Over CBD Inaction During Historic Hearing: The Agency Wants More Money To Do Its Job

By Nina Zdinjak

July 28, 9:53 AM

For the first time, Congress officially addressed the impact of the U.S. Food and Drug Administration’s (FDA) inaction regarding the regulations of CBD products.

JAZZ