FDA

Eton Pharma Wins Big With FDA Hypotension Treatment Approval

Eton Pharmaceuticals Inc. (NASDAQ: ETON) shares jumped on Tuesday after the firm announced that the U.S. Food and Drug Administration (FDA) has approved Biorphen. Biorphen is the first and only ...
Read Full Story »

New Osteoarthritis Treatment Has to Wait Even Longer for FDA Approval

Flexion Therapeutics Inc. (NASDAQ: FLXN) has announced that the U.S. Food and Drug Administration (FDA) informed the company that it needs additional time to complete the review of the supplemental ...
Read Full Story »

Major Step Forward in Peanut Allergy Treatment

DBV Technologies S.A. (NASDAQ: DBVT) shares dipped early Monday after the firm announced an update from the U.S. Food and Drug Administration (FDA). Although it was a positive update for ...
Read Full Story »

America’s Unsafe Medical Products

The U.S. Food and Drug Administration (FDA) issued seven new safety alerts in the final two weeks of September, six related to product recalls and one safety communication related to ...
Read Full Story »

Is the FDA Going Too Soft on Zantac?

The U.S. Food and Drug Administration (FDA) is coming down hard after the disclosure that Zantac and other generic ranitidine drugs could contain impurities and carcinogens. Instead of just a ...
Read Full Story »

FDA Accepts for Review the Newest Treatment for C Diff

Merck & Co. Inc. (NYSE: MRK) has just announced that the U.S. Food and Drug Administration (FDA) accepted a couple New Drug Applications (NDAs) for review. Specifically, the FDA accepted ...
Read Full Story »

Achillion Pharma Wins Big With FDA Breakthrough

Achillion Pharmaceuticals Inc. (NASDAQ: ACHN) has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for danicopan (ACH-4471) in combination with a C5 monoclonal antibody ...
Read Full Story »

Why This Late-Stage Narcolepsy Study Is Way Ahead of Schedule

Avadel Pharmaceuticals PLC (NASDAQ: AVDL) shares jumped on Monday morning after the firm announced that the U.S. Food and Drug Administration (FDA) has agreed to the company’s proposed amendments to ...
Read Full Story »

Will This Ebola Vaccine Be the Next Big Thing?

NewLink Genetics Corp. (NASDAQ: NLNK) shares jumped on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) has accepted Merck & Co.’s (NYSE: MRK) Biologics License ...
Read Full Story »

Good News, Bad News in the War on Peanut Allergy

Aimmune Therapeutics Inc. (NASDAQ: AIMT) shares dipped on Monday after the Allergenic Products Advisory Committee (APAC) convened by the U.S. Food and Drug Administration (FDA) voted to support the use ...
Read Full Story »

7 Biotechs With Catalysts in the Next Month

If there is one area that can generate riches for speculative investors, it would have to be biotech and emerging pharmaceuticals. After all, how many companies can go from nothing ...
Read Full Story »

FDA Gets Off the Pot for IBS Treatment Approval

Ardelyx Inc. (NASDAQ: ARDX) shares dropped sharply on Friday after the firm announced that the U.S. Food and Drug Administration (FDA) has approved its treatment of irritable bowel syndrome with ...
Read Full Story »

Great News for Patients With Dangerously Low Blood Sugar

Xeris Pharmaceuticals Inc. (NASDAQ: XERS) shares were halted briefly on Tuesday after the firm announced that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for ...
Read Full Story »

Is the FDA Canceling This Schizophrenia Treatment?

Intra-Cellular Therapies Inc. (NASDAQ: ITCI) shares dipped on Tuesday after the firm gave an update from the U.S. Food and Drug Administration (FDA). Essentially, the FDA informed Intra-Cellular that it ...
Read Full Story »

Why This New Dementia Study Is a Huge Hit

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) shares rose sharply early Monday after the firm announced that its late-stage dementia study met its primary endpoint. Specifically, the results come from Acadia’s Phase ...
Read Full Story »