FDA - Spark Newswire

5 minute read

The Daily Biotech Pulse: Priority Review For Amgen’s Asthma Treatment, Evaxion Reports Positive Skin Cancer Readout, Quidel Recalls Lyra COVID-19 Test

Today, 10:34 PM

Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs July 7)

ABCL

2 minute read

Biogen Announces FDA Approval Of Updated ADUHELM Prescribing Information

By Bill Haddad

Today, 10:34 PM

Biogen (NASDAQ:BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced the U.S. Food and Drug Administration (FDA) has approved an updated label for ADUHELM™ (aducanumab-avwa) injection 100 mg/mL

BIIB

2 minute read

Pluristem Says Is Bringing ‘ARDS Associated with COVID-19 Phase II Studies’ To Clinical Readout; Topline Results Expected During Q4

By Bill Haddad

Today, 10:34 PM

The company will analyze data based on patients enrolled to date in COVID-19 Phase II studies in U.S., Europe and Israel Topline results are expected during the fourth quarter of

PSTI

1 minute read

Amgen – AstraZeneca’s Asthma Candidate Under Priority Review With FDA

By Vandana Singh

Today, 10:34 PM

The FDA has accepted for review Amgen Inc’s (NASDAQ:AMGN) marketing application seeking approval for tezepelumab to treat asthma. Amgen is developing…

AMGN

1 minute read

SeaSpine Stock Is Trading Higher On FDA Approval For 7D Surgical Spine Module

By Vandana Singh

Today, 10:34 PM

The FDA has given 510(k) clearance to SeaSpine Holdings Corporation’s (NASDAQ:SPNE) 7D Percutaneous Spine Module for minimally invasive surgery. This news follows…

SPNE

1 minute read

Quidel Recalls Lyra COVID Diagnostic Test Due To Potential False Negative Results

By Vandana Singh

Today, 10:34 PM

Quidel Corporation (NASDAQ:QDEL) is recalling its Lyra COVID-19 Assay test due to a high risk of false-negative results in patients with…

QDEL

2 minute read

FDA
News

AstraZeneca Announced Tezepelumab Regulatory Submission Accepted and Granted FDA Priority Review in the U.S. for Treatment of Patients With Asthma

By Charles Gross

Today, 10:34 PM

AstraZeneca's (NYSE: AZN) Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen.

AZN

1 minute read

Quidel Shares Tick Lower, Quickly Rebound Following Circulation Of FDA Recall For Co.’s ‘Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results’

By Benzinga Newsdesk

Today, 10:34 PM

https://www.fda.gov/medical-devices/medical-device-recalls/quidel-recalls-lyra-sars-cov-2-assay-m120-due-risk-false-negative-results

QDEL

1 minute read

Valneva’s Chikungunya Vaccine Candidate Gets FDA Breakthrough Tag

By Vandana Singh

Today, 10:34 PM

The FDA grants Breakthrough Therapy Designation to Valneva SE’s (NASDAQ:VALN) single-shot chikungunya vaccine candidate, VLA1553. This new U.S. milestone comes in addition…

VALN

1 minute read

WHO Recommends IL-6 Drugs From Sanofi, Roche For Critically-Ill COVID-19 Patients

By Vandana Singh

Today, 10:34 PM

The World Health Organization (WHO) has endorsed Interleukin-6 (IL-6) receptor antagonists combined with corticosteroids to treat severe COVID-19 cases. Patients…

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