FDA

Meet the FDA’s Newest Fast Tracked Zika Virus Treatment

Moderna, Inc. (NASDAQ: MRNA) shares jumped late on Monday after the firm announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational Zika ...
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Why the FDA Is a Little Slow on This Jet Lag Study

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) shares dropped early to begin the week after the firm announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug ...
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Good News for Stem Cell Transplants

Akari Therapeutics PLC (NASDAQ: AKTX) shares jumped on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its stem cell ...
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Breakthrough Gastrointestinal Tumor Therapy Reaches New Milestone

Deciphera Pharmaceuticals Inc. (NASDAQ: DCPH) shares nearly doubled on Tuesday after the firm announced top-line results from its late-stage trial treating patients with gastrointestinal stromal tumors (GIST). Specifically, this data ...
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Is Amarin’s Cardio Trial in Trouble?

Amarin Corp. PLC (NASDAQ: AMRN) shares dropped on Friday after the firm announced that it received notice from the U.S. Food and Drug Administration (FDA). According to the notice, the ...
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Is Intra-Cellular’s Schizophrenia Treatment in Trouble?

Intra-Cellular Therapies Inc. (NASDAQ: ITCI) saw its shares dip on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) has canceled the Psychopharmacologic Drugs Advisory Committee ...
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Tuesday’s Biggest Biotech Movers

Despite this truncated trading week, Tuesday was a breakout day for a few biotech companies. In this case, all these companies saw a solid gain. With the markets back near ...
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Why Akorn Is in Trouble With the FDA Again

Akorn Inc. (NASDAQ: AKRX) shares dipped on Tuesday after the firm announced that it received a warning letter from the U.S. Food and Drug Administration (FDA). Specifically, this letter is ...
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FDA Ignites Ocular Inflammation Treatment Dextenza in Most Recent Approval

Ocular Therapeutix, Inc. (NASDAQ: OCUL) shares jumped on Friday after the firm announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Dextenza ...
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Why This FDA Approval for Pneumonia Treatment Is So Huge

This story has been updated for share price impact. Melinta Therapeutics, Inc. (NASDAQ: MLNT) shares nearly doubled early on Wednesday after the firm announced that the U.S. Food and Drug ...
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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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