FDA, Atara

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,
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
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.
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.
Atara Biotherapeutics reports clinical hold placed on Ebvallo programs, ATA3219
Atara Biotherapeutics (ATRA) announced that the FDA has placed a clinical hold on Atara’s active investigational new drug, or IND,
Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its Ebvallo and ATA3219 programs due to compliance issues at a third-party manufacturing facility.
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 ...
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FDA Accepts J&J's Filing for Autoimmune Disease Drug Nipocalimab
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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 ...
FDA lifts clinical hold on Amylyx ALS drug study
Shares of Amylyx Pharmaceuticals (NASDAQ:AMLX) fell 13% in morning trading Tuesday amid news that an FDA clinical hold on a Phase 1 study for its ALS drug candidate AMX0114 has been lifted. Amylyx ...
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FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer
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Dyne Therapeutics Gains ‘Buy’ Rating Following FDA Fast Track Designation and Promising Trial Results
Analyst Michael Ulz of Morgan Stanley maintained a Buy rating on Dyne Therapeutics (DYN – Research Report), retaining the price target of ...
FDA accepts Replimune's advanced melanoma therapy BLA
Replimune Group Inc (NASDAQ: NASDAQ:REPL), a biotech firm focused on oncolytic immunotherapies, announced today that its Biologics License Application (BLA) for RP1 in combination with nivolumab has ...