FDA Archives - Page 214 of 220

1 minute read

Beigene’s Inspections Delay Suggest Eventual Approval, Says This Analyst

July 14, 2:53 PM

Beigene Limited (NASDAQ: BGNE) provided a regulatory update on the anticipated US approval decision for the Biological License Application for tislelizumab in 2L metastatic esophageal squamous cell carcinoma (ESCC).

BGNE

1 minute read

Why Novavax Shares Are Plunging Today Despite Much Awaited FDA Emergency Nod?

By Vandana Singh

July 14, 1:24 PM

The European Medicines Agency identified severe allergic reactions as potential side effects of Novavax Inc’s (NASDAQ:NVAX) COVID-19 vaccine. A few cases of…

NVAX

1 minute read

Summit Therapeutics Mulls Additional Trial For Its Once Failed Infection Candidate

By Vandana Singh

July 14, 11:35 AM

Summit Therapeutics Inc (NASDAQ:SMMT) provided an update on the clinical development of ridinilazole, its lead Phase 3 product candidate for Clostridioides…

SMMT

1 minute read

U.S. FDA Defers Decision On BeiGene’s Filing For Esophageal Carcinoma Due To Pending Inspection

By Ragothaman Srinivasan

July 14, 10:33 AM

The U.S. Food and Drug Administration (FDA) has deferred decision on the Biologics License Application (BLA) for BeiGene’s (NASDAQ: BGNE) tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

BGNE

1 minute read

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

By Ragothaman Srinivasan

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

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

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