FDA

A Common Ingredient in Many Supplements Is Dangerous for Pregnant Women

Contents of some herbal supplements sold across the country in vitamin and nutrition stores may pose a significant danger to some people. The U.S. Food and Drug Administration (FDA) is ...
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Why the FDA Is Crushing Nabriva’s UTI Treatment

Nabriva Therapeutics PLC (NASDAQ: NBRV) shares dropped sharply on Wednesday after the firm received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New ...
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What CRISPR Has Planned for Transfusion-Dependent Beta Thalassemia

When CRISPR Therapeutics A.G. (NASDAQ: CRSP) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CTX001 for the treatment of transfusion-dependent beta thalassemia, its ...
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Bad News for Epilepsy Seizure Patients Following FDA Update

Zogenix Inc. (NASDAQ: ZGNX) shares were crushed on Tuesday after the firm provided an update from the U.S. Food and Drug Administration (FDA). Unfortunately, the agency sent a Refusal to ...
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What’s Next for PhaseBio’s Antiplatelet Reversal Agent

PhaseBio Pharmaceuticals Inc. (NASDAQ: PHAS) shares made a sizable gain on Tuesday morning after the U.S. Food and Drug Administration provided a critical update for the firm. Specifically, the FDA ...
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What’s Next for Axsome Therapeutics After This FDA Approval

Axsome Therapeutics Inc. (NASDAQ: AXSM) shares jumped on Wednesday after the firm said it received an update from the U.S. Food and Drug Administration (FDA). Essentially, the agency granted Breakthrough ...
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Bad News for AbbVie and Multiple Myeloma Patients

AbbVie Inc. (NYSE: ABBV) and patients suffering from multiple myeloma have seen some additional bad news. The Food and Drug Administration (FDA) has placed a partial clinical hold on clinical ...
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Great News for Adolescents with Moderate to Severe Atopic Dermatitis

In an incredible move for adolescent patients 12 to 17 years of age, the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for patients with moderate-to-severe atopic dermatitis. ...
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Alarming Trends on E-Cigarette Use Among High School and Middle School Students

It is supposed to be undeniable that smoking and using any forms of tobacco is bad for your health. And the rate of smoking cigarettes has been on the decline ...
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Major 2019 Biopharma Catalysts Coming in February and March

Biotech and pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. The amount of risk involved ranges from fair to ...
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Asthma and COPD Patients Score With Generic Advair Diskus FDA Approval

More and more branded drugs seem to be facing generic competition. The impact might not be so positive for Big Pharma giants, but this can be a serious victory for ...
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Can Editas Survive After Losing Its CEO?

Editas Medicine Inc. (NASDAQ: EDIT) shares were crushed on Tuesday after the company announced that its president and chief executive, Katrine Bosley, would be stepping down from these roles effective ...
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Is Immunomedics Breast Cancer Treatment Doomed After This FDA Update?

Immunomedics Inc. (NASDAQ: IMMU) shares were crushed on Friday after the firm received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). Usually, CRLs can spell ...
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Why the FDA Is Coming Down on Akorn

Akorn Inc. (NASDAQ: AKRX) shares dipped on Wednesday after the company received a warning letter from the U.S. Food and Drug Administration (FDA). The letter is in relation to an ...
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Major Biopharma Catalysts Coming in the First Quarter of 2019

Biotech and pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. The amount of risk involved ranges from fair to ...
Read Full Story »