Le Lézard

Communiqués de presse par sujet : Approbation de la FDA (Food and Drug Administration)

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11 octobre 2017

08:44
HORSHAM, Pa., Oct. 11, 2017 /PRNewswire/ -- Janssen Biotech, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen...


10 octobre 2017

21:00
TOKYO, Oct. 10, 2017 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of...

09:53
MINNETONKA, Minn., Oct. 10, 2017 /PRNewswire/ -- Respicardia, Inc., a private medical technology company, announced today that it received U.S. Food and Drug Administration (FDA) approval of its remed?® System, a transvenous implantable...

09:00
SAN DIEGO, Oct. 10, 2017 /PRNewswire/ -- Today, Ansun BioPharma announced that the Division of Antiviral Products of the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Ansun's first-in-class experimental...

09:00
RIDGEFIELD, Conn., Oct. 10, 2017 /PRNewswire/ -- Boehringer Ingelheim today announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug...

08:30
NOVATO, California, TOKYO and LONDON, October 10, 2017 /PRNewswire/ -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, Kyowa Hakko Kirin Co.,...


9 octobre 2017

07:00
BURLINGTON, Mass., Oct. 9, 2017 /PRNewswire/ -- Flexion Therapeutics, Inc. (Nasdaq: FLXN) will hold a conference call today, Monday, October 9, 2017, at 8:00 a.m. ET to discuss the recent U.S. Food and Drug Administration (FDA) approval of ZILRETTAtm...


6 octobre 2017

16:59
SILVER SPRING, Md., Oct. 6, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The Remed? System is an...

08:07
CONCORD, Calif., Oct. 6, 2017 /CNW/ -- The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic...


5 octobre 2017

17:39
SILVER SPRING, Md., Oct. 5, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from...

16:01
MARLBOROUGH, Mass., Oct. 5, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Panther Fusion® Flu A/B/RSV assay running on the new...

11:57
SANTA ANA, Calif., Oct. 5, 2017 /PRNewswire/ -- McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuff Company, Inc. announces the United States Food and Drug Administration's New Drug Approval (NDA) of Ascor® (Ascorbic Acid Injection...

07:00
SUNNYVALE, Calif., Oct. 5, 2017 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Strep A. The test provides rapid, accurate, and reliable molecular...

07:00
SAN DIEGO, Oct. 5, 2017 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved an 80 mg INGREZZA® (valbenazine) capsule strength to be used for the treatment of adults...


4 octobre 2017

17:16
BOTHELL, Wash., Oct. 4, 2017 /PRNewswire/ -- Solta Medical, a division of Valeant Pharmaceuticals North America LLC, announced today that its Thermage FLXtm System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to...

16:16
NEW YORK, Oct. 4, 2017 /PRNewswire/ -- Peerbridge Health Inc., a Health IT company, announced today that its first product, the Peerbridge Cortm System -- a wireless electrocardiogram (ECG) monitor -- has received 510(k) clearance from the U.S. Food...

13:00
OXFORD, England, October 4, 2017 /PRNewswire/ -- FDA issues final Guidance for Industry, transferring regulatory authority to EPA  Following new Guidance issued by the U.S. Food and Drug Administration's Center for Veterinary Medicine (FDA-CVM),...

10:14
WATERLOO, ON, Oct. 4, 2017 /PRNewswire/ - Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received the approval of the CE Mark (Conformité Européenne) for its intellijoint HIP® System in Europe. A 3D...

09:54
HAMPTON, Va., Oct. 4, 2017 /PRNewswire/ -- On September 29, 2017, the U.S. Food and Drug Administration (FDA) proposed an extension of the compliance dates for the final rules mandating changes to food, beverage, and supplement labeling.  The...

09:00
CARLSBAD, California, Oct. 4, 2017 /PRNewswire/ -- Applied Spectral Imaging (ASI), a global leader in computer-assisted biomedical imaging, announced today the launch of PathFusiontm and HiPath Protm, innovative Brightfield and FISH imaging &...

08:00
New Thermage FLXtm System Reduces Treatment Time by 25 Percent and Enhances Patient Comfort LAVAL, Quebec, Oct. 4, 2017 /PRNewswire/ -- Solta Medical, a division of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant"),...

04:00
EDINBURGH, Scotland, October 4, 2017 /PRNewswire/ -- CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has secured new equity funding. Existing investors,...


3 octobre 2017

20:08
HERTFORDSHIRE, England, and PITTSBURGH, Oct. 3, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate...

09:00
SALT LAKE CITY, Oct. 3, 2017 /PRNewswire/ -- DiscGenics, Inc., a clinical stage regenerative medicine company focused on developing regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine,...

08:00
PLEASANTON, Calif., Oct. 3, 2017 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced immediate plans to initiate screening of blood samples with the cobas® Babesia test under an Investigational New Drug Application protocol. The cobas®...

07:31
DUBLIN, Oct. 3, 2017 /PRNewswire/ -- Today Allergan plc (NYSE:AGN) announced the FDA approval of BOTOX® Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis...

07:00
REDWOOD CITY, Calif., Oct. 3, 2017 /PRNewswire/ -- Carrot Inc. announced today that its Carbon Monoxide Breath Sensor System has been cleared by the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) commercial use in smoking...


2 octobre 2017

16:05
HILDEN, Germany and GERMANTOWN, Maryland, October 2, 2017 /PRNewswire/ -- QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that its manufacturing and supply chain for consumables and other products for forensic and human identity...

12:39
HERTFORDSHIRE, England and PITTSBURGH, Oct. 2, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Caspofungin Acetate for Injection, one of the first generic versions of Merck's Cancidas®. Mylan received final...

08:00
DUBLIN, Oct. 2, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and...

07:00
WALTHAM, Mass., Oct. 2, 2017 /PRNewswire/ -- Alere Inc. (NYSE: ALR), a global leader in rapid diagnostics, today announced that its Aleretm i Influenza A & B 2 test has received 510(k) marketing clearance from the U.S. Food and Drug Administration...

06:56
PHILADELPHIA, Oct. 2, 2017 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-Release...


29 septembre 2017

16:59
HERTFORDSHIRE, England and PITTSBURGH, Sept. 29, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis's Gleevec® Tablets. Mylan received...

11:03
PLAINSBORO, N.J., Sept. 29, 2017 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycemic...


28 septembre 2017

14:25
SILVER SPRING, Md., Sept. 28, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2...

09:00
OR AKIVA, Israel, September 28, 2017 /PRNewswire/ -- Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced FDA 510(k)...

07:00
TORONTO, Sept. 28, 2017 /PRNewswire/ -- Impopharma Inc. ("Impopharma") today announced that it has entered into an asset purchase, license, and commercialization agreement with Breckenridge Pharmaceutical, Inc. ("Breckenridge"). Under terms of the...


27 septembre 2017

18:41
- REVOLUTIONARY SYSTEM TO REPLACE BLOOD GLUCOSE MONITORING, ELIMINATING THE NEED FOR ROUTINE FINGER STICKS(1) AND FINGER STICK CALIBRATION - EASY-TO-USE(2), LONGER LASTING AND LESS BULKY(3) THAN OTHER CONTINUOUS GLUCOSE MONITORS AVAILABLE IN U.S....

17:42
ABBOTT PARK, Ill., Sept. 27, 2017 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the FreeStyle® Libre Flash Glucose Monitoring System as a replacement1 for blood glucose monitoring...

17:24
SILVER SPRING, Md., Sept. 27, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients...

08:00
MARLBOROUGH, Mass., Sept. 27, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted an expanded FDA 510(k) clearance for Cynosure's non-invasive body contouring...

07:00
ISFIYA, Israel and BOSTON, Sept. 27, 2017 /PRNewswire/ --Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) (NASDAQ: CHEKW), a clinical-stage medical diagnostics company engaged in the development of C-Scan®, an ingestible capsule for...

06:51
PHILADELPHIA, Sept. 27, 2017 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Oxycodone and Acetaminophen...

06:00
DALLAS, Sept. 27, 2017 /PRNewswire/ -- Fotona, based in the U.S. and Europe, has received FDA clearance for its new StarWalker® MaQX Q-Switched laser system for treating tattoos, pigmented and vascular lesions, acne and scar revision and even...

06:00
PORT WASHINGTON, N.Y., Sept. 27, 2017 /PRNewswire/ -- Pall Medical, a division of Pall Corporation ? a global leader in filtration, separation and purification ? is pleased to announce that its QPoint® Water Filter Capsules have received FDA 510(k)...


26 septembre 2017

14:23
WOODCLIFF LAKE, N.J., Sept. 26, 2017 /PRNewswire/ -- Eisai Inc. today announced the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (marketed as Lenvima®) for the potential...

08:35
LOGAN, Utah, Sept. 26, 2017 /PRNewswire/ -- Mortise Medical, a start-up medical device company focused on advanced soft tissue repair systems for ankle injuries, announces that it has recently received FDA 510(k) clearance for its innovative...

06:53
PHILADELPHIA, Sept. 26, 2017 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Dexmethylphenidate...


25 septembre 2017

08:00
NESS ZIONA, Israel and CHAPEL HILL, North Carolina, Sept. 25, 2017 /PRNewswire/ -- Atox Bio today announced that it has been awarded the next option on a performance-based contract with the Biomedical Advanced Research and Development Authority...

08:00
MONROE TOWNSHIP, N.J., Sept. 25, 2017 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced that the U.S. Food and Drug Administration (FDA)...

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