FDA Archives - Page 160 of 220

3 minute read

AIM ImmunoTech Announces FDA Clearance Of IND Application To Evaluate Ampligen In Phase 2 Clinical Study For The Treatment Of Post-COVID Conditions

October 12, 8:46 AM

AIM ImmunoTech Inc. (NYSE:AMERICAN) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune

AIM

1 minute read

Frequency Therapeutics Completes Enrollment Of Phase 2b Study Of FX-322 For The Treatment Of Sensorineural Hearing Loss

By Bill Haddad

October 12, 7:31 AM

Frequency Therapeutics, Inc. (NASDAQ:FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a person's innate potential to restore function, today announced that it has

FREQ

1 minute read

Tiziana Life Sciences Plans To Submit IND For Phase 1 Trial Of Intranasal Foralumab In Alzheimer’s Disease Patients

By Bill Haddad

October 12, 7:02 AM

Tiziana Life Sciences Ltd. (NASDAQ: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announcedTiziana Life Sciences Ltd.

TLSA

4 minute read

Dyne Therapeutics Presents Preclinical Data From Its Duchenne Muscular Dystrophy Programs Targeting Exons 51 and 53 At World Muscle Society 2022 Congress October 11-15

By Benzinga Newsdesk

October 11, 4:26 PM

- Poster Highlights In Vivo Data for DYNE-251, Now Being Evaluated in Phase 1/2 DELIVER Clinical Trial in Patients Amenable to Exon 51 Skipping - - First Presentation of In Vitro Data for FORCE™ Platform

DYN

3 minute read

Avidity Biosciences Announces Phase 1/2 EXPLORE44 Trial Of AOC 1044 For Duchenne Muscular Dystrophy Mutations Amenable To Exon 44 Skipping

By Benzinga Newsdesk

October 11, 4:06 PM

AOC 1044 is the first antibody oligonucleotide conjugate (AOC™) of multiple Duchenne muscular dystrophy programs to enter the clinic First AOC from Avidity's RNA platform technology engineered to deliver

RNA

1 minute read

Gilead’s Trodelvy Under FDA Review For Pre-Treated HR+/HER2- Metastatic Breast Cancer

By Vandana Singh

October 11, 2:37 PM

The FDA has accepted for review Gilead Sciences Inc’s (NASDAQ:GILD) Trodelvy (sacituzumab govitecan-hziy) for unresectable locally advanced or metastatic hormone receptor…

GILD

1 minute read

FDA Highlights Quality Check Issues At Eli Lilly’s New Jersey Manufacturing Site

By Vandana Singh

October 11, 2:35 PM

An inspection in July by the FDA revealed several issues surrounding quality control at Eli Lilly And Co's (NYSE: LLY) manufacturing site in Branchburg, NJ.

LLY

4 minute read

Allogene Therapeutics Launches CAR T Together, A First-Of-Its-Kind Initiative With Oncologists Nationwide, Focused On Accelerating Development And Clinical Trial Recruitment For “Off-The-Shelf” Allogeneic Cell Therapy Investigational Products

By Benzinga Newsdesk

October 11, 8:37 AM

New Survey Focused on Access Limitations of Approved Autologous CAR T Therapies Reveals Only 50% of Eligible Cancer Patients Receive Treatment Increased Patient Demand, Manufacturing Capacity and Time to

ALLO

2 minute read

Cocrystal Pharma Selects CDI-988 For Clinical Development As An Oral Treatment For COVID-19

By Benzinga Newsdesk

October 11, 8:17 AM

BOTHELL, Wash., Oct. 11, 2022 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (NASDAQ:COCP) announces the selection of its novel, broad-spectrum antiviral drug candidate CDI-988 for clinical development as an

COCP

1 minute read

FDA
News

FDA Cites Eli Lilly for New Quality-control Problems at Drug Factory in New Jersey

By Charles Gross

October 11, 6:01 AM

-Reuters Citing FDA Document

LLY