Biotech Archives - Page 781 of 795

1 minute read

Lantern Pharma Gets FDA Clearance for Mid-Stage Lung Cancer Study

July 14, 9:31 AM

The Food and Drug Administration (FDA) has announced clearance to Lantern Pharma (NASDAQ: LTRN) to proceed with Phase 2 clinical trial of its investigational new drug LP-300 in combination with chemotherapy for never smoker patients with advanced non-small cell lung cancer (N

LTRN

1 minute read

Pasithea Therapeutics Awarded $694K Drug Development Research Grant

By Bill Haddad

July 14, 8:06 AM

-- AUD $1 million (U.S $694,000) grant transferred as part of Alpha-5 Integrin, LLC transaction -- -- Provides approximately U.S. $694,000 of non-dilutive funding -- MIAMI BEACH, Fla., July 14, 2022 (GLOBE NEWSWIRE) --

KTTA

2 minute read

Amryt Receives Orphan Drug Designation From The FDA For Mycapssa For The Treatment Of Carcinoid Syndrome

By Benzinga Newsdesk

July 14, 7:03 AM

Amryt (NASDAQ:AMYT), a global, commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce that the US Food and Drug

AMYT

1 minute read

Lantern Pharma Receives FDA Authorization To Initiate Its Phase 2 Clinical Trial, Harmonic, For LP-300 In Never Smokers With Non-Small Cell Lung Cancer

By Benzinga Newsdesk

July 14, 7:01 AM

The Harmonic™ trial is a Phase 2 multi-center study focused on never smokers with advanced non-small cell lung cancer (NSCLC) and will begin patient enrollment during Q3 2022. In a previous Phase 3

LTRN

1 minute read

Regeneron-Sanofi’s Dupixent Hits Primary Goal In Esophagitis Patients Below 11 Years

By Vandana Singh

July 14, 6:18 AM

Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA’s (NASDAQ:SNY) Phase 3 trial of Dupixent (dupilumab) in children aged 1 to 11 years…

REGN

1 minute read

BeiGene Provides Regulatory Update On The U.S. Biologics License Application For PD-1 Inhibitor Tislelizumab In 2L ESCC

By Benzinga Newsdesk

July 14, 6:05 AM

FDA Defers Action on BLA Until Required Inspections Can Be Completed Due to COVID Travel Restrictions, Inspections Could Not Be Completed During Review Period

BGNE

1 minute read

Novavax Secures FDA Emergency Authorization For Adjuvanted Covid-19 Vaccine

By Ragothaman Srinivasan

July 13, 5:59 PM

The U.S. Food and Drug Administration (FDA) grants emergency use authorization (EUA) to Novavax’s (NASDAQ: NVAX) lead candidate Adjuvanted (NVX-CoV2373) COVID-19 Vaccine for individuals 18 years of age and over.

NVAX

2 minute read

Why BioNTech Is Trading Higher Today Following A Stock Upgrade From SVB Securities Analyst

By Dylan Wechsler

July 13, 5:13 PM

SVB Securities, a division of SVB Financial Group (NASDAQ: SIVB), believes BioNTech SE – ADR (NASDAQ: BNTX) stock is trading below the most negative scenario for the COVID-19 vaccine mar

BNTX

1 minute read

ContraFect Shares Plummet After Data Safety Monitoring Board Stops Late-Stage Aureus Bacteremia Study

By Ragothaman Srinivasan

July 13, 4:42 PM

The Data Safety Monitoring Board (DSMB) has recommended that ContraFect’s (NASDAQ: CFRX) on going DISRUPT trial be stopped because the conditional power of the study was below the pre-specified threshold for futility.

CFRX

1 minute read

Ensysce Biosciences Announces Initial Patients Dosed Of First Human Abuse Potential Study

By Bill Haddad

July 13, 4:08 PM

Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance

ENSC