Nasdaq FDA - Search News

Atara extends losses after FDA clinical hold

Atara Biotherapeutics (ATRA) stock slips as company faces an FDA clinical hold after rejection of lead candidate Ebvallo. Read more here.

Business Insider · 1d

Atara Biotherapeutics Faces Strategic Uncertainty Amid FDA Hold and CRL Issues

H.C. Wainwright analyst Robert Burns has reiterated their neutral stance on ATRA stock, giving a Hold rating yesterday.Invest with Confidence:

Reuters on MSN · 2d

US FDA puts clinical hold on Atara's trials for cancer cell therapies

Atara Biotherapeutics said on Tuesday the U.S. health regulator had placed a clinical hold on its trials for cancer cell therapies, sending the drug developer's shares down more than 4% in premarket trading.

Hosted on MSN · 2d

Sanofi says FDA lifted clinical hold on trial for Cialis OTC switch

Sanofi’s (NASDAQ:SNY) consumer healthcare unit Opella announced Tuesday that the U.S. FDA has lifted a clinical hold on a trial designed to test an over-the-counter version of its erectile dysfunction (ED) drug,

Business Insider · 2d

Atara Biotherapeutics Faces Uncertainty Amid FDA Clinical Hold and Financing Needs, Resulting in Hold Rating

Atara Biotherapeutics (ATRA – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Benjamin

4hon MSN

Ionis stock rises on FDA, EMA nod for SMA drug dose increase

Shares of Ionis Pharmaceuticals (NASDAQ:IONS) climbed 7% today after the company announced that regulatory agencies in the ...

Nasdaq13d

FDA Accepts J&J's Filing for Autoimmune Disease Drug Nipocalimab

The FDA filing is supported by data from the phase ... We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that ...

Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia

Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation ...

Hosted on MSN1h

Beta Bionics joins IPO uptick, aims to raise $114.4m in Nasdaq listing

Following a filing revealing its intent to go public in the US on 6 January, artificial pancreas maker Beta Bionics has now set its financial goalposts, aiming to raise $114.4m from the initial public ...

Nasdaq5d

FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...

Nacuity Pharmaceuticals Granted U.S. FDA Fast Track Designation for NPI-001 (N-acetylcysteine amide) Tablets for the Treatment of Retinitis Pigmentosa

A drug that receives Fast Track designation may benefit from more frequent interactions with the FDA throughout drug development. In addition, the Fast Track program allows for Accelerated Approval ...

2don MSN

Replimune stock soars on FDA priority review for melanoma treatment

Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug ...

Nasdaq7d

J&J Seeks FDA Nod for Non-Muscle Invasive Bladder Cancer Drug

Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat certain patients with non-muscle invasive ...

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