FDA - Spark Newswire

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

Today, 4:35 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, 4:35 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

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

By Benzinga Newsdesk

Today, 4:35 PM

- Reuters- Reuters

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

By Charles Gross

Today, 4:35 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

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

By Bill Haddad

Today, 4:35 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

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

By Vandana Singh

Today, 4:35 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, 4:35 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

1 minute read

European Drug Regulator Supports Use Of Pfizer-BioNTech COVID-19 Vaccine In Adolescents: Reuters

By Vandana Singh

Today, 4:35 PM

European Medical Agency backed the use of Pfizer Inc (NYSE:PFE) – BioNTech SE’s (NASDAQ:BNTX) COVID-19 vaccine for children as young as 12,…

BNTX

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FDA
News

Amgen Receives FDA Approval for Lumakras

By Charles Gross

Today, 4:35 PM

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214665

AMGN

1 minute read

Humanigen Files US Emergency Use Application For Lenzilumab For COVID-19

By Vandana Singh

Today, 4:35 PM

Humanigen Inc (NASDAQ:HGEN) has submitted an application to the FDA seeking Emergency Use Authorization (EUA) for lenzilumab to treat patients hospitalized…

HGEN