FDA Archives - Page 169 of 220

2 minute read

FDA Authorizes An Extension Of The In-Use Period For UroGen Pharma’s JELMYTO Admixture To 96 Hours Following Reconstitution

September 28, 8:04 AM

-- This Extension Increases Flexibility and Efficiency for Customers and Patients -- PRINCETON, N.J.--(BUSINESS WIRE)-- UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing

URGN

1 minute read

FDA Approves First Branded Ocular Anesthetic In Almost 14 Years

By Vandana Singh

September 28, 7:09 AM

The FDA approved Harrow Health Inc (NASDAQ:HROW) and Sintetica S.A’s Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia. Iheezo is a…

HROW

7 minute read

TCR2 Therapeutics Announces Topline Results From Phase 1 Portion Of gavo-cel Phase 1/2 Trial; Showed ‘Consistent tumor regression in 28 of 30 (93%) evaluable patients with disease control rate of 77%’

By Bill Haddad

September 28, 6:46 AM

- Completed Phase 1 clinical trial establishes gavo-cel monotherapy as the first anti-mesothelin cell therapy to demonstrate tolerability and clinical benefit - Second RECIST partial response in ovarian cancer supports

TCRR

4 minute read

PepGen Reports Data From Phase 1 Trial Of PGN-EDO51 For Treatment Of Duchenne Muscular Dystrophy

By Bill Haddad

September 28, 6:03 AM

PGN-EDO51 exhibited the highest levels of oligonucleotide delivery and exon skipping in a clinical study following a single dose when compared to publicly available clinical data for other exon 51 skipping

PEPG

2 minute read

Alzheimer’s Progression Slowed Down By Biogen’s New Drug In Late-Stage Study: Analyst Sees 25% Upside For Stock

By Shanthi Rexaline

September 28, 12:35 AM

Biogen, Inc. (NASDAQ: BIIB) and Eisai Co. Ltd. (OTC: ESALY) announced late Tuesday positive results from a late-stage study of their Alzheimer’s treatment candidate.

BIIB

1 minute read

FDA
News

Thermo Fisher Scientific Announces FDA Approval Of Oncomine Dx Target Test As First NGS-Based Companion Diagnostic To Aid In Therapy Selection For Patients With RET Mutations/Fusions In Thyroid Cancer

By Michael Horton

September 27, 4:33 PM

-Reuters

TMO

1 minute read

TCR² Therapeutics To Announce Complete Phase 1 Portion Of The Gavo-Cel Phase 1/2 Clinical Trial For Mesothelin-Expressing Solid Tumors September 28th

By Benzinga Newsdesk

September 27, 4:17 PM

CAMBRIDGE, Mass., Sept. 27, 2022 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (NASDAQ:TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from solid tumors,

TCRR

1 minute read

FDA To Review Smaller Number Of Emergency Use Requests For COVID-19 Tests

By Vandana Singh

September 27, 2:14 PM

The FDA said it will now review only a small number of emergency use authorization (EUA) requests for COVID-19 diagnostic…

1 minute read

Why Are Bellerophon Shares Jumping Today?

By Vandana Singh

September 27, 12:07 PM

The FDA has accepted Bellerophon Therapeutics Inc’s (NASDAQ:BLPH) proposal to reduce the study size for its ongoing registrational REBUILD Phase 3…

BLPH

1 minute read

FDA
News

Tarsus To Present Saturn-2 Pivotal Phase 3 Trial Data And Saturn-1 Extension Study Long-term Safety Data Evaluating TP-03 For The Treatment Of Demodex Blepharitis At Upcoming Eye Care Meetings

By Benzinga Newsdesk

September 27, 12:01 PM

Tarsus Pharmaceuticals, Inc. (NASDAQ:TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that the

TARS