Le Lézard

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

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16 août 2017

12:08
SINGAPORE, Aug. 16, 2017 /PRNewswire/ -- US FDA has granted two orphan drug designations (ODD) for T cell therapy products to Singapore-based biotech company, Lion TCR Pte Ltd, for the treatment of hepatocellular carcinoma (HCC). Lion TCR are...

08:51
DUBLIN, Aug. 16, 2017 /PRNewswire/ -- Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Mycolog® II Cream...

02:51
STOCKHOLM, Aug 16, 2017 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR) announces today that the Investigational New Drug (IND) application for MIV-711 has been accepted and the IND is now open with the FDA (U.S. Food and Drug Administration)....


15 août 2017

08:08
WAYNE, Pa., Aug. 15, 2017 /PRNewswire/ -- Camber Spine Technologies announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRAtm Open Matrix ALIF device, a unique, interbody fusion...


11 août 2017

16:31
SILVER SPRING, Md., Aug. 11, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida,...

09:30
REDLANDS, Calif., Aug. 11, 2017 /PRNewswire/ -- Renovis Surgical Technologies, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market posterior lumbar Tesera® porous titanium interbody...

07:00
CARLSBAD, Calif., Aug. 11, 2017 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) today reported that the Company has retained all rights to inotersen and IONIS-FB-LRx. As part of a reprioritization of its pipeline and strategic...


9 août 2017

11:02
STOCKHOLM, August 9, 2017 /PRNewswire/ -- InDex Pharmaceuticals Holding AB (publ) today announced that the US Food and Drug Administration (FDA) has granted orphan-drug designation for the drug candidate cobitolimod for treatment of ulcerative...

07:15
MALVERN, Pa., Aug. 9, 2017 /PRNewswire/ -- Ocugen, Inc., a clinical stage biopharmaceutical company developing novel treatments for sight-threatening diseases, today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug...


8 août 2017

10:32
NORTHFIELD, Minn., Aug. 8, 2017 /PRNewswire/ -- AUM Cardiovascular announced that it has received clearance from the Food and Drug Administration for CADence,tm a non-invasive acoustic and ECG device designed to help physicians detect physiological...

08:30
JERSEY CITY, N.J., Aug. 8, 2017 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc., today announced RADICAVA tm (edaravone), an intravenous therapy indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS), also known as...

08:08
WEST DRAYTON, England, August 8, 2017 /PRNewswire/ -- The Scottish Medicines Consortium (SMC) has announced today a positive decision for the use of NOQDIRNA®.[1] NOQDIRNA® is the only licensed treatment for the symptomatic treatment of nocturia...


7 août 2017

16:17
LAVAL, Quebec, Aug. 7, 2017 /CNW/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug...

09:37
FARMVILLE, N.C., Aug. 7, 2017 /PRNewswire/ -- CMP Pharma today announced that the US Food and Drug Administration (FDA) has granted final approval of the company's New Drug Application (NDA) for CaroSpir® (Spironolactone Oral Suspension, 25 mg/5mL),...

08:00
HERTFORDSHIRE, England and PITTSBURGH, Aug. 7, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S....

08:00
DUBLIN AND SAN FRANCISCO, Aug. 7, 2017 /PRNewswire/ -- Allergan plc (NYSE:AGN), a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality...

07:00
PARAMUS, N.J., Aug. 7, 2017 /PRNewswire/ -- Polaryx Therapeutics, Inc, a biotech company developing oral small molecule therapeutics for Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL) and for other forms of NCL, commonly known as Batten...

04:00
KERALA, Inde, August 7, 2017 /PRNewswire/ -- L'extrait de curcuma BCM-95® reçoit une «  No Questions Letter » (lettre de non-objection) de la part de la FDA   La curcumine BCM-95® d'Arjuna Naturals Extracts Ltd., un extrait de curcuma hautement...


4 août 2017

09:35
ARLINGTON, Va., Aug. 4, 2017 /PRNewswire-USNewswire/ -- The Society of Chemical Manufacturers and Affiliates (SOCMA) Bulk Pharmaceuticals Task Force today commends the U.S. Senate on passage of the Food and Drug Administration Reauthorization Act of...

09:20
DUBLIN, Aug. 4, 2017 /PRNewswire/ -- Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Mirvaso® (brimonidine) topical gel 0.33%. Perrigo...


3 août 2017

15:32
SILVER SPRING, Md., Aug. 3, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver...

15:28
NORTH CHICAGO, Ill., Aug. 3, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved MAVYRETtm (glecaprevir/pibrentasvir), a once-daily, ribavirin-free...

14:49
RYE BROOK, N.Y., Aug. 3, 2017 /PRNewswire-USNewswire/ -- The Leukemia & Lymphoma Society (LLS) applauds the U.S. Food and Drug Administration (FDA) approval today of CPX-351 (VyxeosTM), an innovative combination of two chemotherapy drugs being used...

14:04
VERNON HILLS, Ill., Aug. 3, 2017 /PRNewswire/ -- Nexus Pharmaceuticals announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Isoproterenol Hydrochloride...

10:15
DUBLIN, Aug. 3, 2017 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company will host a webcast on Monday, August 7, 2017 at 4:30 p.m. EDT/9:30 p.m. IST to provide investors with an update on Vyxeostm (daunorubicin...

10:10
Vyxeos represents the first new chemotherapy advance in more than 40 years for these adults with AML Vyxeos improved overall survival compared to standard of care 7+3 (cytarabine and daunorubicin) regimen (9.6 months vs. 5.9 months, respectively)...

09:53
SILVER SPRING, Md., Aug. 3, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML...

07:00
JERUSALEM, August 3, 2017 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ: NTEC) (TASE: NTEC), a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pilltm platform technology, announces the results from...

05:00
KERALA, India, August 3, 2017 /PRNewswire/ -- BCM-95® Turmeric Extract Granted a 'No Questions' Letter from the FDA  Arjuna Naturals Extracts Ltd.'s BCM-95®, a high-potency turmeric extract, has been granted a 'No Questions' response letter...


2 août 2017

21:23
SHANGHAI and TAIPEI, Aug. 2, 2017 /PRNewswire/ -- WuXi Biologics (2269.HK), a global leading open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and its partner...

16:49
HORSHAM, Pa., Aug. 2, 2017 /PRNewswire/ -- Janssen Biotech, Inc. announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) did not recommend approval of sirukumab (proposed trade name PLIVENSIAtm) for the...

13:32
HORSHAM, Pa., Aug. 2, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of...

13:07
NORTH CHICAGO, Ill., Aug. 2, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with...

11:48
SILVER SPRING, Md., Aug. 2, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of...


1 août 2017

15:49
RYE BROOK, N.Y., Aug. 1, 2017 /PRNewswire-USNewswire/ -- Today marks another significant advance in the offensive against acute myeloid leukemia (AML), one of the most deadly blood cancers that takes more than 10,000 lives in the U.S. each year. The...

13:00
PRETORIA, South Africa, Aug. 1, 2017 /PRNewswire/ -- Xavant Technology (Pty) Ltd today announced that the U.S. Food and Drug Administration (FDA) cleared their Stimpod NMS460. With the U.S. patent awarded on proprietary hybrid pulsed radio frequency...

11:31
SILVER SPRING, Md., Aug. 1, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific...

09:08
GAITHERSBURG, Md., Aug. 1, 2017 /PRNewswire/ -- Sirnaomics, Inc. (www.sirnaomics.com), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today that the Office of Orphan Product Development division of...

08:00
ST. LOUIS, Aug. 1, 2017 /PRNewswire/ -- The Food and Drug Administration authorized the use of a qualified health claim confirming soybean oil's ability to reduce the risk of coronary heart disease.1 Soybean oil is the most widely used edible oil in...


31 juillet 2017

15:20
TEL AVIV, Israel, July 31, 2017 /PRNewswire/ -- Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug...

12:07
ST. LOUIS, July 31, 2017 /PRNewswire/ -- Bunge North America, the North American arm of Bunge Limited (NYSE: BG), is pleased to announce that the U.S. Food and Drug Administration (FDA) approved its petition for a qualified health claim linking...

09:00
THOUSAND OAKS, Calif., July 31, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 980, a biosimilar...

07:30
SUNNYVALE, Calif., July 31, 2017 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its iDMStm Data Management System, enabling its use with the...

07:00
BILLERICA, Mass., July 31, 2017 /PRNewswire/ -- Bruker today announces that it has received US Food & Drug Administration (FDA) clearance for its third, further expanded claim for the market-leading MALDI Biotyper-CA (MBT-CA) system for fast,...

07:00
POMONA, Calif., July 31, 2017 /PRNewswire/ -- Immunalysis Corporation, a division of Alere Inc. (NYSE: ALR), today announced that its SEFRIAtm Fentanyl Urine Enzyme Immunoassay has been granted 510(k) clearance by the U.S. Food and Drug...


28 juillet 2017

09:00
LAS VEGAS, July 28, 2017 /PRNewswire/ -- Under the Orphan Drug Act (ODA), drugs, vaccines, and diagnostic agents qualify for orphan status if they are intended to treat a disease affecting less than 200,000 American citizens. Orphan drug sponsors...

08:00
MONROE TOWNSHIP, N.J., July 28, 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 the U.S. Food and Drug Administration (FDA)...


27 juillet 2017

17:49
THOUSAND OAKS, Calif., July 27, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen's supplemental Biologics License Application (sBLA) for...

11:28
CHICAGO, July 27, 2017 /PRNewswire/ -- Quantitative Insights, Inc. (QI) today announced that it has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA) for its QuantXtm Advanced system, the...

10:00
MORTSEL, Belgium and GREENVILLE, South Carolina, July 27, 2017 /PRNewswire/ -- The XERO Viewer is part of Agfa HealthCare's award-winning Enterprise Imaging platform, which consolidates imaging data from multiple service lines and provides secure...

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