FDA

Meet the FDA’s Newest Fast Tracked Zika Virus Treatment

Posted: August 19, 2019 at 4:12 pm

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 ...
Read Full Story »

Why the FDA Is a Little Slow on This Jet Lag Study

Posted: August 19, 2019 at 8:55 am

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 ...
Read Full Story »

Good News for Stem Cell Transplants

Posted: August 14, 2019 at 9:45 am

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 ...
Read Full Story »

Breakthrough Gastrointestinal Tumor Therapy Reaches New Milestone

Posted: August 13, 2019 at 10:00 am

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 ...
Read Full Story »

Is Amarin’s Cardio Trial in Trouble?

Posted: August 9, 2019 at 10:50 am

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 ...
Read Full Story »

Is Intra-Cellular’s Schizophrenia Treatment in Trouble?

Posted: July 24, 2019 at 12:05 pm

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 ...
Read Full Story »

Tuesday’s Biggest Biotech Movers

Posted: July 2, 2019 at 10:20 am

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 ...
Read Full Story »

Why Akorn Is in Trouble With the FDA Again

Posted: June 25, 2019 at 9:55 am

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 ...
Read Full Story »

FDA Ignites Ocular Inflammation Treatment Dextenza in Most Recent Approval

Posted: June 21, 2019 at 10:08 am

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 ...
Read Full Story »

Why This FDA Approval for Pneumonia Treatment Is So Huge

Posted: June 19, 2019 at 9:23 am

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 ...
Read Full Story »

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 ...
Read Full Story »

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 ...
Read Full Story »

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 ...
Read Full Story »

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 ...
Read Full Story »

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 ...
Read Full Story »