FDA Archives - Spark Newswire

2 minute read

Capricor Therapeutics Announces Follow-Up Type-B Clinical Meeting With The FDA For CAP-1002 For The Treatment Of Duchenne Muscular Dystrophy

Yesterday, 9:17 AM

Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases,

CAPR

1 minute read

Cue Health Becomes First Company to Receive FDA De Novo Authorization COVID-19 Home Use Test

By Vandana Singh

Yesterday, 8:54 AM

Cue Health Inc (NASDAQ: HLTH) became the first company to receive De Novo authorization from the FDA for its Cue COVID-19 Molecular Test, designed for both home and

HLTH

1 minute read

FDA Prioritizes GSK’s Breakthrough Drug Jemperli for Endometrial Cancer Treatment, a First in Decades

By Vandana Singh

June 6, 9:36 AM

The FDA accepted the supplemental marketing application for GSK Plc’s (NYSE:GSK) Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with…

GSK

1 minute read

Why Are Timber Pharmaceuticals Shares Trading Higher Today

By Vandana Singh

June 5, 8:31 AM

The FDA has granted dermal carcinogenicity (CARC) waiver for Timber Pharmaceuticals Inc's (NYSE: TMBR) TMB-001, a topical isotretinoin formulated using the company's patented IPEG delivery system.

TMBR

4 minute read

Theratechnologies Receives FDA Agreement To Amended Trial Protocol For Its Lead PDC Candidate Sudocetaxel Zendusortide

By Happy Mohamed

June 2, 12:18 PM

Phase 1 trial to resume with weekly dosing, a focus on patients with ovarian cancer and refined patient selection June 13 call for investors and analysts with trial investigators to provide insights on

THTX

2 minute read

Arcturus Therapeutics Receives U.S. FDA Fast Track Designation For ARCT-810, mRNA Therapeutic Candidate For Ornithine Transcarbamylase Deficiency

By Happy Mohamed

June 1, 8:32 AM

Arcturus Therapeutics Holdings Inc. ((the "Company", "Arcturus", NASDAQ:ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines

ARCT

3 minute read

Psyched: LSD Microdosing For Depression, DMT For Anxiety, MDMA Octopuses And More

By Lara Goldstein

May 31, 11:59 AM

Microdosing LSD For Major Depression Treatment Seeks Further Clinical Validation Via New Study Australian psychedelics company MindBio Therapeutics Corp. was granted approval by both the Ethics committee and the Clinical Trials Registry to begin the world's first Phase 2a take-home LSD microdosing trial in patients with Major Depressive Disorder (MDD).

CMPS

3 minute read

FDA Presents Potential Framework For CBD, From Edibles To Delta-8, Reaffirms Congress Is In Charge

By Nina Zdinjak

May 30, 10:20 AM

The U.S. Food and Drug Administration has not given up on regulating CBD and hemp-derived products in a way that would be safe for consumers and producers.

JAZZ

1 minute read

Morphogenesis, CohBar Announce Acceptance of Abstract For Poster Presentation At 2023 ASCO Meeting

By Benzinga Newsdesk

May 30, 8:06 AM

Details of the presentation are as follows:Title: Phase 1b trial of IFx-Hu2.0, a novel personalized cancer vaccine, in checkpoint inhibitor resistant Merkel cell carcinoma and cutaneous squamous cell carcinomaAbstract #:

CWBR

3 minute read

Lexicon Announces FDA Approval Of INPEFA For Treatment Of Heart Failure

By Happy Mohamed

May 26, 4:07 PM

INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes INPEFA reduced the risk of total occurrence of

LXRX