U.S. Food and Drug Administration

Roche gets breakthrough status for Alzheimer's test Elecsys

ZURICH (Reuters) - The U.S. Food and Drug Administration has granted Roche an accelerated review for its Elecsys product used to diagnose Alzheimer's disease, the Swiss drugmaker said on Friday.<p>The FDA gave breakthrough device designation to Elecsys, which examines the cerebrospinal fluid in adult …

Alzheimer's Disease

Agios Pharmaceuticals leukemia drug gets U.S. approval

(Reuters) - Agios Pharmaceuticals Inc said on Friday the U.S. Food and Drug Administration approved its treatment for a type of leukemia, the first targeted drug for patients with a specific genetic mutation.<p>The company plans to launch the drug, Tibsovo, in the United States in about 48 hours, …

Myeloid Leukemia

Attorneys general want flavored tobacco banned in all tobacco products

Nine attorneys general are urging the U.S. Food and Drug Administration to ban all flavored tobacco products, which lead middle and high school …

FDA

Chinese pharma firm recalls heart drug in U.S. after possible impurity

BEIJING (Reuters) - The Chinese bulk manufacturer of the common blood and heart drug valsartan said it was recalling the product from consumers in the United States and would halt supplies to the country, after an impurity linked to cancer had been detected.<p>Earlier this week, European regulators …

FDA

Allergan, Molecular Partners eye drug meets main goal in two studies

(Reuters) - Allergan Plc and Molecular Partners AG said on Thursday their treatment for neovascular age-related macular degeneration, a leading cause of vision loss among people over 65, met the main goal in two late-stage studies.<p>FILE PHOTO: The Allergan logo is seen in this photo illustration …

Atoms

Mersana's cancer drug trial put on hold by FDA; shares halted

(Reuters) - Mersana Therapeutics said on Thursday an early stage trial testing its lead cancer drug has been put on partial hold by the U.S. Food and Drug Administration after a patient's death was possibly linked to the treatment.<p>No new patients will be enrolled in the study, but the current …

Cancer

Electric toothbrush recalled for fire danger

NATIONWIDE – A malfunctioning toothbrush is being recalled after warnings that it might overheat and potentially cause a fire.<p>Water Pik, Inc. issued …

Austin

Former hospital pharmacy tech charged in NECC-related case

A former Massachusetts hospital employee is now facing a federal charge related to the 2012 nationwide meningitis outbreak that killed more than 70 …

General Hospital

FDA Defends Decision To Reclassify Alternative Milks As ‘Nut Sweat’

SILVER SPRINGS, MD—Addressing concerns that the naming practice could unfairly bias consumers against the products, the U.S. Food and Drug …

Humor

Hy-Vee recalls spring pasta salad tied to salmonella cases

DES MOINES, Iowa (AP) — Midwest grocery store chain Hy-Vee Inc. has recalled its store-brand spring pasta salad after 20 people got salmonella in …

South Dakota

FDA issues recall for blood pressure medication due to cancer risk

- The U.S. Food and Drug Administration has issued a recall for several drugs used to treat high blood pressure and heart failure due to the risk of …

High Blood Pressure

FDA approves Dermira's wipe for excessive armpit sweating

(Reuters) - Dermira Inc (DERM.O) said on Friday its topical cloth for excessive armpit sweating was approved by the U.S. Food and Drug Administration, providing patients with an easy-to-use option for an often embarrassing condition.<p>Shares of the company were up more than 25 percent at $11.09 in …

FDA

Puma Biotech gets EU panel nod for breast cancer drug

(Reuters) - Puma Biotechnology Inc on Friday won a key recommendation from a European Medicines Agency panel on its lead breast cancer drug, five months after the regulator recommended against approving it.<p>Shares of Puma, which on Tuesday signaled the committee was likely to give positive opinion …

Breast Cancer

Imperial Brands invests in cannabis-based medical research

LONDON (Reuters) - Tobacco company Imperial Brands is investing in Oxford Cannabinoid Technologies, to help the British biotech company research how marijuana can be used in medicine.<p>The maker of Gauloises and Winston cigarettes said on Thursday that its subsidiary, Imperial Brands Ventures, was …

Cannabis

From Meditation to Medication: Headspace Has a Prescription Strategy

The mindfulness app plans a new company with the goal of developing FDA-approved treatments for health problems<p>You might know Headspace as a meditation app. What if it were also a prescription medication?<p>The California-based company recently launched Headspace Health, a subsidiary whose executives’ …

Mindfulness

Roche gets priority review from FDA for Hemlibra

ZURICH (Reuters) - Roche has been given fast-track review by the U.S. Food and Drug Administration (FDA) for its Hemlibra treatment for people with a form of haemophilia, the Swiss drugmaker said on Tuesday.<p>FILE PHOTO: Swiss drugmaker Roche's logo is seen at their headquarters in Basel, Switzerland …

FDA

Loxo-Bayer cancer drug gets priority review from FDA

(Reuters) - Loxo Oncology and Bayer AG said on Tuesday the U.S. Food and Drug Administration granted priority review to their cancer drug and would decide on the marketing application by Nov. 26.<p>A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August …

FDA

BRIEF-Nabriva Announces Positive Results For Pneumonia Treatment

May 21 (Reuters) - Nabriva Therapeutics PLC:<p>* NABRIVA THERAPEUTICS ANNOUNCES POSITIVE TOPLINE RESULTS FROM PIVOTAL PHASE 3 CLINICAL TRIAL OF ORAL LEFAMULIN FOR THE TREATMENT OF COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA<p>* NABRIVA THERAPEUTICS PLC - COMPANY PLANS TO FILE A NEW DRUG APPLICATION WITH U.S. …

FDA

BRIEF-Foundation Medicine's New Liquid Biopsy Assay Granted Breakthrough Device Designation By U.S. FDA

April 26 (Reuters) - Foundation Medicine Inc:<p>* FOUNDATION MEDICINE’S NEW LIQUID BIOPSY ASSAY GRANTED BREAKTHROUGH DEVICE DESIGNATION BY U.S. FOOD AND DRUG ADMINISTRATION<p>* FOUNDATION MEDICINE- NEW ASSAY WILL INCLUDE OVER 70 GENES, GENOMIC BIOMARKERS FOR MICROSATELLITE INSTABILITY & BLOOD TUMOR …

FDA

BRIEF-Astellas Pharma Submits NDA For Approval Of Gilteritinib

April 23 (Reuters) - Astellas Pharma Inc:<p>* ASTELLAS SUBMITS NEW DRUG APPLICATIONS FOR APPROVAL OF GILTERITINIB FOR THE TREATMENT OF FLT3MUT+ RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA<p>* ASTELLAS PHARMA INC-SUBMITTED A NDA FOR APPROVAL OF GILTERITINIB IN SAME PATIENT POPULATION TO U.S. FOOD AND …

FDA

Ex-Aveo Pharmaceuticals CFO must face SEC trial, judge rules

A federal judge on Friday cleared the way for the U.S. Securities and Exchange Commission to take Aveo Pharmaceuticals Inc’s former chief financial officer to trial over claims he misled investors in connection with the company’s efforts to develop a cancer drug.<p>U.S. District Judge Nathaniel Gorton …

Law

BRIEF-Rigel Pharmaceuticals NDA For Tavalisse Approved By FDA

April 17 (Reuters) - U.S. Food And Drug Administration:<p>* RIGEL PHARMACEUTICALS NDA FOR TAVALISSE APPROVED BY FDA Source text: (bit.ly/2HGn96a) Further company coverage:

FDA

FDA Bans Sale of Caffeine in Bulk Directly to Consumers

Small amounts of pure caffeine products have proven to be dangerous and even fatal, regulator says<p>Online shopping has made it easy for consumers to affordably buy highly concentrated caffeine in bulk, whether to mix it into a workout shake or using it as an alternative to a morning coffee.<p>However, …

FDA

FDA needs more time to review AbbVie, Neurocrine's uterine pain drug

(Reuters) - AbbVie Inc and Neurocrine Biosciences Inc said on Tuesday the U.S. Food and Drug Administration notified the companies that it requires more time to review the marketing application for their uterine pain drug.<p>FILE PHOTO: A screen displays the share price for pharmaceutical maker AbbVie …

FDA

FDA Recalls Kratom Products For Salmonella Threat

Environmental Health

Occult Gynecologic Cancer in Women Undergoing Hysterectomy... : Obstetrics & Gynecology

Departments of Obstetrics, Gynecology and Reproductive Sciences and Internal Medicine and the Cancer Outcomes, Public Policy and Effectiveness …

Cancer

Daré Bioscience's (DARE) CEO Sabrina Martucci Johnson on Q4 2017 Results - Earnings Call Transcript

Daré Bioscience Inc. (NASDAQ:DARE) Q4 2017 Earnings Conference Call April 2, 2018 4:30 PM ET<p><b>Executives</b><p>Sabrina Martucci Johnson – President and Chief …

Biotechnology

Endo Agrees to Extend Temporary Stay of FDA Litigation

DUBLIN, April 2, 2018 /PRNewswire/ -- Endo International plc (ENDP) today announced that it has agreed to extend a temporary stay of its litigation …

Biotechnology

European Medicines Agency (EMA) Accepts BioMarin's Marketing Application for Pegvaliase MAA for Treatment of Phenylketonuria (PKU)

<b>FDA PDUFA Action Date for Pegvaliase is May 25, 2018</b><p>SAN RAFAEL, Calif., March 28, 2018 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN) announced …

Biotechnology

20 Years Later, Viagra Means Something Different For Millennials

A new generation is redefining what it means to take the pill.<p>Jason K. was 27 the first time he tried to have sex with a woman and couldn’t get an …

Bob Dole