Blog Posts - U.s Food And Drug Administration



Nordstrom (JWN) Bullish Expectations; Onconova (ONTX) Soars on FDA Submission for HR-MDS Drug

Nordstrom Inc. (JWN) The price of JWN stock surged more than 5% in after-hours trading Thursday as the company delivered quarterly profit numbers above Wall Street analysts’ expectations For its second quarter 2015, JWN posted net sales of $3.6...
by CRWE-PR Finance on Aug 14, 2015

Strong Momentum Signals: Inotek Pharmaceuticals (ITEK), Cara Therapeutics (CARA)

Inotek Pharmaceuticals Corp. (ITEK) The price of ITEK stock skyrocketed more than 50% in early trading Thursday as the company announced that the Phase 3 development strategy of its lead glaucoma drug, trabodenoson, a first-in-class selective adenosi...
by CRWE-PR Finance on Jul 23, 2015

Charles Frischer Bets on Newcastle Investment (NCT); Cantor Sees Upside Potential in Relypsa (RLYP)

Newcastle Investment Corp. (NCT) Charles Frischer disclosed in a regulatory filing ( SC 13D ) with the Securities and Exchange Commission (SEC) a 5.2% (3,442,000 shares) stake in NCT. NCT reported a key measure of profitability in its first quarter 2...
by CRWE-PR Finance on Jul 7, 2015

Hansen Medical (HNSN) and Tesla Motors (TSLA) Momentum Signals; Progress Software (PRGS) Surpasses Forecasts

Hansen Medical, Inc. (HNSN) After the closing bell on Wednesday, HNSN said that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Magellan(TM) 10Fr Robotic Catheter for use in the peripheral vasculature. HNSN‘s Magell...
by CRWE-PR Finance on Jul 2, 2015

GW Pharma (GWPH) New High, Momentum Factors; BTIG Research Strong Perspective on Netflix (NFLX)

GW Pharmaceuticals plc (GWPH) Shares of GWPH surged to touch an all-time high of $129.62 on Monday’s trading session. GWPH recently commenced the second of two Phase 3 clinical trials of Epidiolex(R) (cannabidiol or CBD) for the treatment of Le...
by CRWE-PR Finance on Jun 23, 2015

Aerie Pharma (AERI) Soars on FDA- Feedback; Buffett’s Berkshire (BRK.A) (BRK.B) Makes Strategic Move

Aerie Pharmaceuticals, Inc. (AERI) Shares of AERI soared more than 40% in after-hours trading Monday as the company said that the U.S. Food and Drug Administration (FDA) has agreed in written and verbal communications that AERI may change the primary...
by CRWE-PR Finance on Jun 16, 2015

St. Jude Medical (STJ) FDA OKs Brain Implant for Parkinson’s Symptoms; Charles Schwab (SCHW) PT Boosted

 St. Jude Medical Inc. (STJ) The U.S. Food and Drug Administration (FDA) has approved STJ‘s Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremo...
by CRWE-PR Finance on Jun 13, 2015

FDA Approves Brain Implant to Help Reduce Parkinson’s Disease and Essential Tremor Symptoms

Las Vegas, NV / CRWEPRESSRELEASE / June 12, 2015 / The U.S. Food and Drug Administration today approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential...
by CRWE-PR Finance on Jun 12, 2015

GW Pharmaceuticals Initiates Second Phase 3 Pivotal Study of Epidiolex(R) (CBD) in Lennox-Gastaut Syndrome

London, UK / CRWEPRESSRELEASE / 11 June 2015 / GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics fr...
by CRWE-PR Finance on Jun 11, 2015

Retrophin (RTRX) At All-Time High Levels on RE-024 FDA-Status, Syneron (ELOS) Settles Legal Battle

Retrophin, Inc. (RTRX) Shares of RTRX touched an all-time high in after-hours trading Thursday as the company said that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its novel investigational phosphopantothenate r...
by CRWE-PR Finance on Jun 5, 2015

Heron Therapeutics (HRTX) Momentum on Top-Line Study Results; Is Rosetta Stone (RST) a Takeover Target?

Heron Therapeutics, Inc. (HRTX) Shares of HRTX soared to reach a record high in extended-hours trading Thursday after the company reported positive, top-line results from its recently completed Phase 3 MAGIC study. According to HRTX, its 5-HT3 recept...
by CRWE-PR Finance on May 29, 2015

Nevro (NVRO) Attracts Bay City Capital; Point72 Asset Shows Confidence In Bloomin’ Brands (BLMN)

Nevro Corp. (NVRO) Bay City Capital LLC, a life sciences investment firm, disclosed in a regulatory filing ( Form SC 13G ) with the Securities and Exchange Commission (SEC) that it owns 2,217,214 shares of NVRO, representing an 8.9% stake in the comp...
by CRWE-PR Finance on May 24, 2015

Study Shows Light Cigarettes Are a Proven Way to Reduce Nicotine Intake

Good news this week if you’re a smoker who wants to look at quitting or at least reducing the harm caused by cigarettes. This is especially true because the cost of smoking is so much more than simply the cost of cigarettes. The results of a n...
by Debt Free Living Guru on Aug 24, 2014

Project Prepper, Part 20: Bottled Water’s ‘Indefinite’ Safety Shelf Life

A week ago, I shared with readers some helpful information I recently came across concerning the long-term storage of emergency water. In the days that followed, I received a comment (hat tip WinstonSmith) that reminded me of something I had read a w...
by Survival And Prosperity on Aug 29, 2013

Salad Mix recall traced to Taylor Farms

Taylor Farms products on the grocery shelves have not been linked.On July 30, the states of Iowa and Nebraska announced their analysis indicated the outbreak in those states was linked to a salad mix. In follow-up to that announcement, the U.S. Foo...
by Barbara's Beat on Aug 2, 2013

Enteric Coated Aspirin Tablets recalled due to health risk after Acetaminophen found in bottle

Advance Pharmaceutical Inc. announced a recall of the over-the-counter drug product, Rugby label Enteric Coated Aspirin Tablets, 81 mg, Lot 13A026. Advance Pharmaceutical Inc. first initiated the recall on June 17, after receiving a complaint about...
by Barbara's Beat on Jun 29, 2013

Pfizer settles first case in Chantix suicide litigation

Averting trial of a closely watched bellwether products-liability case, Pfizer Inc. (NYSE: PFE) settled claims the pharmaceutical maker failed to state adequately the psychiatric risks–including suicide–associated with use of the company’s smok...
by Law & Industry Daily on Oct 19, 2012

Pfizer settles first case in Chantix suicide litigation

Averting trial of a closely watched bellwether products-liability case, Pfizer Inc. (NYSE: PFE) settled claims the pharmaceutical maker failed to state adequately the psychiatric risks–including suicide–associated with use of the company’s smok...
by Law & Industry Daily on Oct 19, 2012

Pfizer settles first case in Chantix suicide litigation

Averting trial of a closely watched bellwether products-liability case, Pfizer Inc. (NYSE: PFE) settled claims the pharmaceutical maker failed to state adequately the psychiatric risks–including suicide–associated with use of the company’s smok...
by Law & Industry Daily on Oct 19, 2012

FDA recalls cantaloupe by Chamberlain Farms of Owensville Indiana

Fast factsThe U.S. Food and Drug Administration is recalling cantaloupe by Chamberlain Farms, of Owensville, Indiana, because of possible contamination with Salmonella Typhimurium associated with a multi-state outbreak of salmonellosis. The FDA is...
by Barbara's Beat on Aug 24, 2012


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