Biotech - Spark Newswire

1 minute read

Akebia Therapeutics Stock Jumps as FDA Accepts Vadadustat US Application in CKD-Related Anemia

Today, 11:36 PM

Akebia Therapeutics Inc (NASDAQ:AKBA) and its collaborator Otsuka Holdings (OTC:OTSKY) have announced that the FDA has accepted to review vadadustat’s marketing application for…

AKBA

1 minute read

Sanofi Stops Venglustat Development In Rare Genetic Kidney Disorder

By Vandana Singh

Today, 11:36 PM

Sanofi SA (NASDAQ:SNY) has halted the clinical program of venglustat in autosomal dominant polycystic kidney disease (ADPKD). Although the safety profile…

SNY

1 minute read

FDA
News

Lannett Announces FDA Acceptance, As A Priority Original ANDA, Of The Generic Advair Diskus Filing

By Bill Haddad

Today, 11:36 PM

Lannett Company, Inc. (NYSE:LCI) today announced the U.S. Food and Drug Administration (FDA) has accepted the Abbreviated New Drug Application (ANDA) for Fluticasone Propionate and Salmeterol inhalation powder (100/50

LCI

7 minute read

The Week Ahead In Biotech: ASCO Presentations Front And Center, FDA Decisions Due For Scynexis, Liminal And Alkermes

By Shanthi Rexaline

Today, 11:36 PM

After having declined through the first half of the week, biotech stocks staged a recovery to close higher in the trading week ended May 28. Broader market sentiment and company-specific news flow dictated stock moves during the week.

ADAP

1 minute read

FDA
News

Kroger Is Voluntarily Recalling Its Chicken Street Taco Kit Due To Undeclared Egg

By Benzinga Newsdesk

Today, 11:36 PM

- Reuters- Reuters

2 minute read

Pfizer and BioNTech Confirm First Authorization in European Union for COVID-19 Vaccine in Adolescents

By Charles Gross

Today, 11:36 PM

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age.

BNTX

1 minute read

FDA
News

BridgeBio Pharma’s Affiliate QED Therapeutics And Partner Helsinn Group Announce FDA Approval Of TRUSELTIQ For Patients With Cholangiocarcinoma

By Bill Haddad

Today, 11:36 PM

Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring an FGFR2 fusion

BBIO

1 minute read

Amgen’s First KRAS-Targeted Therapy, Lumakras Scores FDA Approval For Lung Cancer

By Vandana Singh

Today, 11:36 PM

The FDA has given accelerated approval to Amgen Inc’s (NASDAQ:AMGN) Lumakras (sotorasib) for non-small cell lung cancer (NSCLC) patients harboring kras mutation.…

AMGN

2 minute read

FDA
News

Amgen Press Release Confirms FDA Approved LUMAKRAS For Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

By Benzinga Newsdesk

Today, 11:36 PM

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS™ (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic

AMGN