FDA

A Common Ingredient in Many Supplements Is Dangerous for Pregnant Women

Posted: June 5, 2019 at 8:44 am

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

Posted: May 1, 2019 at 9:55 am

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

Posted: April 16, 2019 at 12:15 pm

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

Posted: April 9, 2019 at 10:05 am

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

Posted: April 9, 2019 at 9:05 am

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

Posted: March 27, 2019 at 10:45 am

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

Posted: March 19, 2019 at 10:25 am

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

Posted: March 11, 2019 at 4:14 pm

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

Posted: February 11, 2019 at 2:34 pm

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

Posted: February 8, 2019 at 8:40 am

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

Posted: January 30, 2019 at 4:23 pm

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?

Posted: January 22, 2019 at 1:00 pm

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?

Posted: January 18, 2019 at 9:50 am

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

Posted: January 9, 2019 at 12:15 pm

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

Posted: January 7, 2019 at 8:35 am

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 »