FDA Archives - Page 65 of 220

4 minute read

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

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

2 minute read

Marinus Pharmaceuticals Receives Positive Committee For Medicinal Products For Human Use Opinion For ZTALMY For The Adjunctive Treatment Of Seizures Associated With CDKL5 Deficiency Disorder

By Happy Mohamed

May 26, 8:13 AM

The European Commission decision is expected within 67 days of the CHMP opinion Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat

MRNS

2 minute read

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval For Opdivo With Chemotherapy As Neoadjuvant Treatment Of Resectable Non-Small Cell Lung Cancer At High Risk Of Recurrence In Patients With Tumor Cell PD-L1 Expression

By Happy Mohamed

May 26, 8:12 AM

Recommendation based on results from the Phase 3 CheckMate -816 trial, in which Opdivo with chemotherapy demonstrated improved event-free survival and pathologic complete response compared to chemotherapy alone

BMY

2 minute read

Immutep Announces Publication Of Abstracts For ASCO 2023 Annual Meeting

By Happy Mohamed

May 26, 8:07 AM

Media Release New data published from Part C of TACTI-002 Phase II Trial evaluating eftilagimod alpha plus pembrolizumab in metastatic 2nd line head and neck squamous cell carcinoma Deep, durable responses seen

IMMP

1 minute read

FDA
News

Relay Therapeutics Announces Full Dose Escalation Data For RLY-4008

By Benzinga Newsdesk

May 25, 5:06 PM

Relay Therapeutics, Inc. (NASDAQ:RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today announced complete

RLAY