FDA Archives - Page 32 of 220

6 minute read

Takeda Announces Late-Breaking Data From Phase 2b Study Of TAK-279, An Investigational, Oral, Once-Daily TYK2 Inhibitor, In Patients With Active Psoriatic Arthritis At American College Of Rheumatology Convergence Annual Meeting

November 7, 11:01 AM

− The Study Met Its Primary Endpoint with 53.3% and 54.2% of Patients Treated With TAK-279 (15 mg and 30 mg Respectively) Achieving At Least an ACR 20 Response Compared to 29.2% in the Placebo Group at Week 12 (p =

TAK

3 minute read

Psyched: DEA’s Denial Overruled, Fed Psychedelics Change, Psilocybin For Depression, States Reform & More

By Lara Goldstein

November 6, 8:02 PM

DEA Psilocybin Rescheduling Denial Overruled By Federal Appeals Court

ATAI

5 minute read

Aura Biosciences Receives FDA Agreement Under Special Protocol Assessment For CoMpass Phase 3 Clinical Trial Of Belzupacap Sarotalocan In Early-Stage Choroidal Melanoma

By Benzinga Newsdesk

November 6, 4:01 PM

Positive Clinical Efficacy Updates of Bel-sar for Early-Stage Choroidal Melanoma from the Ongoing Phase 2 Clinical Trial with Suprachoroidal Administration Presented at AAO 2023Preliminary Data from Phase 1 Trial in

AURA

2 minute read

GigaGen, A Subsidiary Of Grifols Presents IND-Enabling Data And Phase 1 Trial Strategy For Its Novel Anti-CTLA-4 Oncology Drug Candidate, GIGA-564, At SITC 2023

By Benzinga Newsdesk

November 6, 9:20 AM

Researchers from the National Cancer Institute will conduct the Phase 1 trial, as established in a recently signed Cooperative Research and Development Agreement (CRADA) GigaGen

GRFS

1 minute read

This Analyst Upgrades Vision Disorder-Focused Outlook Therapeutics’ Prospects After FDA Agreement Despite Investor Concerns

By Vandana Singh

November 3, 3:25 PM

Thursday, Outlook Therapeutics Inc (NASDAQ: OTLK) announced it completed the requested Type A Meetings with the FDA to discuss the

OTLK

3 minute read

FDA Report On Its 50 Years In Cannabis Research, Signals A Boost In Medical Marijuana Prospects

By Nina Zdinjak

November 3, 9:24 AM

Researchers with the Food and Drug Administration (FDA) reported Wednesday on the agency’s 50 years of experience with marijuana research. In an article titled “FDA’s 50

JAZZ

4 minute read

BriaCell Reports Unprecedented Anti-Tumor Activity If Its Next Generation Personalized Breast And Prostate Cancer Immunotherapies In Tumor Models At The 2023 SITC Annual Meeting; FDA Greenlights Bria-OTS IND

By Benzinga Newsdesk

November 3, 8:35 AM

BriaCell demonstrates unprecedented broad immune system activation in tumor models by BriaCell's next generation breast and prostate cancer immunotherapiesData supports further development of BriaCell's next generation

BCTX

1 minute read

Why Is Retinal Disease-Focused Outlook Therapeutics Stock Plunging Today?

By Vandana Singh

November 2, 12:30 PM

Outlook Therapeutics Inc (NASDAQ: OTLK) shares are slumping after the company announced that it has

OTLK

2 minute read

Scilex Holding Company Announces Positive Type C Meeting With The FDA And Reaches Agreement On Path Forward To File An NDA For SP-102 In Lumbosacral Radicular Pain

By Benzinga Newsdesk

November 2, 9:09 AM

Scilex Holding Company (NASDAQ:SCLX, "Scilex" or "Company")))), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute

SCLX