FDA Archives - Page 146 of 220

3 minute read

FDA
News

AstraZeneca’s Imfinzi (Durvalumab) In Combination With Imjudo (Tremelimumab) Plus Platinum-based Chemotherapy Has Been Approved By The Us Fda For The Treatment Of Adult Patients With Stage Iv (Metastatic) Non-small Cell Lung Cancer

November 11, 6:16 AM

AstraZeneca's Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy has been approved in the US for the treatment of adult patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).

AZN

1 minute read

FDA
News

Seagen Announces U.S. FDA Approval Of New Indication For Adcetris For Children With Previously Untreated High Risk Hodgkin Lymphoma

By Benzinga Newsdesk

November 10, 2:14 PM

– Approval Based on Phase 3 Clinical Study That Demonstrated a 59% Reduction in Risk of Disease Progression or Relapse, Second Malignancy or Death vs. Standard of Care –

SGEN

1 minute read

FDA
News

Immutep Announces Clinical Results From Phase II Trial Utilizing Its First-in-class Soluble LAG-3 Protein, Eftilagimod Alpha, In 1st Line NSCLC At SITC 2022 Annual Meeting

By Benzinga Newsdesk

November 10, 12:12 PM

Overall response rate (ORR) increases to 40.4%, according to iRECIST, in TACTI-002 all-comer PD-L1 Phase II trial in 1st line non-small cell lung cancer (1L NSCLC) ORR

IMMP

1 minute read

FDA
News

Pfizer, BioNTech Receive Positive CHMP Opinion For Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster For Children 5 Through 11 Years of Age In European Union

By Benzinga Newsdesk

November 10, 10:45 AM

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5

BNTX

3 minute read

Nurix Announces Initial NX-1607 Phase 1 Data Presented At The 37th Annual Meeting Of The Society For Immunotherapy Of Cancer Demonstrating Targeted CBL-B Inhibition In Patients With Advanced Malignancies

By Benzinga Newsdesk

November 10, 10:20 AM

Biomarker results are a positive demonstration of target engagement for this first-in-class CBL-B inhibitor Biomarker levels achieved with NX-1607 treatment correspond to levels associated with potent anti-tumor

NRIX

1 minute read

FDA
News

Corbus Presents Latest Preclinical Data For CRB-601 At Society For Immunotherapy Of Cancer (SITC) 37th Annual Meeting

By Benzinga Newsdesk

November 10, 10:08 AM

CRB-601 is a potent and selective anti-αvβ8 integrin monoclonal antibody designed to block the activation of latent TGFβ selectively within the tumor microenvironment CRB-601

CRBP

2 minute read

Cybin Provides Progress Update On Its CYB004-E Phase 1 Trial

By Benzinga Newsdesk

November 10, 9:13 AM

Cybin Inc. (NEO:CYBN) (NYSE:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics®, is pleased to announce that its CYB004-E Phase 1

CYBN

2 minute read

Equillium Announces Initiation Of Phase 2 Study Of EQ101 A First-in-Class Multi-Cytokine Inhibitor Of IL-2, IL-9 And IL-15 Targeting Alopecia Areata

By Benzinga Newsdesk

November 10, 9:11 AM

Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that it has

4 minute read

Celyad Oncology Reports Q3 Financial Review As Of September 30, The Company Had Cash And Cash Equivalents Of $13.1M; Clinical Updates Expected By End Of Year For The Phase 1 Dose-escalation IMMUNICY-1 Trial For Lead ShRNA-based Allogeneic Car T Candida…

By Benzinga Newsdesk

November 10, 2:52 AM

Company continues to transition business focus to monetizing unique cell therapy intellectual property and prioritizing R&D discovery Clinical updates expected by end of year for the Phase 1 dose-escalation

CYAD

3 minute read

Molecular Partners Presents Interim Safety And Mechanistic Data From Ongoing Phase 1 Trial Of MP0317 For Treatment of Solid Tumors

By Benzinga Newsdesk

November 10, 2:40 AM

First clinical observation of tumor localized CD40 activation provided by MP0317 No systemic or dose-limiting toxicities observed, a key parameter for CD40 agents Dose escalation remains ongoing with study

MOLN