FDA approval


Evolus (EOLS) Stock Just Got a Major Face-Lift; Mizuho Analyst Weighs In

Congrats. Evolus (EOLS) is the first company to win FDA approval for a neurotoxin that is considered biosimilar to branded Botox for the …

Why Catalyst Pharmaceuticals (CPRX) Is a $6 Stock

Investors in Catalyst Pharmaceuticals (NASDAQ:CPRX) have been waiting for two-and-a-half years since its marketing application was originally submitted to see the company’s flagship candidate …

Synergy Pharmaceuticals Inc Has New IBS-C Indication Under Its Belt, But Can Trulance Succeed Long-Term?

Canaccord’s John Newman finds SGYP’s Trulance commercial potential enticing down the line against its competitors.

Synergy Pharmaceuticals Inc Enters a Fiercely Competitive IBS-C Market, But “Attractive Commercial Opportunities” Exist, Says William Tanner

Now that SGYP has won over FDA approval in a new indication (IBS-C), did the biotech company’s competitive edge just get sharper?

Phil Nadeau Continues to Highlight La Jolla Pharmaceutical Company (LJPC) as “Undervalued” on Back of Giapreza’s Early FDA Victory

Cowen’s Phil Nadeau looks for “rapid adoption” in La Jolla’s Giapreza’s approved wider indication to hike up blood pressure in refractory patients.

Dynavax Technologies Corporation (DVAX) Is Looking at a “Long Commercial Life” Ahead for Its Just-Approved Hepatitis B Vaccine

Cowen believes Dynavax has an asset on its hands that fulfills a valuable unmet need.

Dynavax Technologies Corporation’s (DVAX) Hepatitis B Vaccine Wins FDA Approval

Dynavax Technologies Corporation (NASDAQ:DVAX) has won U.S.

Keryx Biopharmaceuticals (KERX) Announces FDA Approval of Auryxia Tablets as a Treatment for People with Iron Deficiency Anemia and Chronic Kidney Disease, Not on Dialysis; Shares Tumble

Keryx Biopharmaceuticals (NASDAQ:KERX) announced that the FDA has approved Auryxia for an additional indication. The approval is for the treatment of iron deficiency anemia in …

Keryx Biopharmaceuticals (KERX) Auryxia Has Analyst Boris Peaker Expecting Positive Chances for Approval in Pre-Dialysis Today; Here’s Why

Cowen weighs in on encouraging ANS Phase III data expecting green light for KERX’s ferric citrate tablets.

Opko Health Inc. (OPK) Opens Wider Window in CINV Market Thanks to Varubi Approval, Cheers Cantor

Louise Chen notes that under OPK’s agreement with Tesaro, the approval of Varubi IV is a huge win.

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