FDA Archives - Page 83 of 220

3 minute read

Moleculin Announces Presentation Of Pharmacokinetics And Tissue-Organ Distribution Data Demonstrating High Antitumor Activity Of Annamycin In Preclinical Cancer Models

April 18, 1:36 PM

Sponsored research data presented in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023 Annamycin demonstrated increased penetration and accumulation in the liver, which

MBRX

2 minute read

Celcuity Presents Preclinical Data On Therapeutic Effects Of Gedatolisib In Gynecological Cancer Models At AACR Annual Meeting 2023

By Happy Mohamed

April 18, 1:35 PM

Gedatolisib demonstrated superior anti-proliferative potency and efficacy in endometrial, ovarian and cervical cancer cell lines compared to other PAM inhibitors evaluated regardless of PTEN, P13K, or AKT mutational

CELC

2 minute read

Sutro Biopharma Presents Preclinical Data For Its ROR1 Targeting Antibody Drug Conjugate STRO-003 At The AACR Annual Meeting 2023

By Happy Mohamed

April 18, 1:32 PM

Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ:STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced expanded preclinical data for

STRO

3 minute read

Karyopharm Announces Presentation Of Updated Phase 1 Selinexor Data In Patients With Treatment-Naïve Myelofibrosis At AACR 2023

By Happy Mohamed

April 18, 1:31 PM

– At Week 24, 60mg of Selinexor in Combination with Ruxolitinib Achieved: 92% SVR35 and 78% TSS50 in Efficacy Evaluable Population, 79% SVR35 and 58% TSS50 in

KPTI

1 minute read

FDA Gives Green Signal To Second Omicron-Adapted Booster Shots For People At High Risk From Covid

By Vandana Singh

April 18, 11:53 AM

On Tuesday, the FDA amended the emergency use authorizations (EUAs) of Moderna Inc (NASDAQ:MRNA) and Pfizer Inc (NYSE:PFE), and BioNTech SE’s (NASDAQ:BNTX) COVID-19 bivalent mRNA vaccines…

BNTX

4 minute read

Repare Therapeutics Presents Initial Clinical Data From The Phase 1/2 TRESR And ATTACC Trials Evaluating Camonsertib In Combination With Three PARP Inhibitors At The 2023 AACR Annual Meeting

By Happy Mohamed

April 18, 10:16 AM

Camonsertib PARPi combinations demonstrated 48% CBR in patients with unmet medical needs, across tumor types, and regardless of PARPi partner or platinum resistance, with a favorable safety and

RPTX

1 minute read

FDA’s AdComm Panel Favors Innoviva’s Drug For Multidrug-Resistant Bacterial Infections

By Vandana Singh

April 18, 9:22 AM

The FDA’s Antimicrobial Drugs Advisory Committee unanimously voted 12-0 in support of approval of Innoviva Inc’s (NASDAQ:INVA) sulbactam-durlobactam for hospital-acquired bacterial pneumonia…

INVA

2 minute read

Erasca Presents Promising Initial Phase 1b Dose Escalation Data From FLAGSHP-1 For ERAS-601 Plus Cetuximab In Patients With Advanced Solid Tumors At The 2023 AACR Annual Meeting

By Happy Mohamed

April 18, 9:04 AM

ERAS-601, a potential best-in-class SHP2 inhibitor, blocks oncogenic signal transduction to delay onset of therapeutic resistance Combination was well-tolerated; supports ‘three weeks on, one week off'

ERAS

3 minute read

Nuvalent Presents New Preclinical Data Supporting Intracranial Activity Of NVL-655 At AACR Annual Meeting 2023

By Happy Mohamed

April 18, 9:02 AM

Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the presentation of new

NUVL

4 minute read

Immuneering Announces Initial Phase 1 Pharmacokinetic, Pharmacodynamic And Safety Data For IMM-1-104 Universal-RAS Program; Accelerates Study Timeline

By Happy Mohamed

April 18, 9:01 AM

Data presented at AACR Annual Meeting support IMM-1-104's potential to address a broad population of patients with RAS mutant tumors IMM-1-104 well tolerated with no dose limiting toxicities (DLTs) or serious

IMRX