Le Lézard

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

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5 juillet 2017

14:37
BOCA RATON, Fla., July 5, 2017 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today it has received U.S. Food and Drug Administration final approval of its abbreviated new drug application (ANDA) for Omeprazole delayed-release capsules,...

09:00
IRVINE, Calif., July 5, 2017 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it received U.S. Food...


3 juillet 2017

13:34
SILVER SPRING, Md., July 3, 2017 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling...


30 juin 2017

08:00
ATLANTA and LAUSANNE, Switzerland, June 30, 2017 /PRNewswire/ -- Arbor Pharmaceuticals, LLC, a U.S.-based specialty pharmaceutical company, and Debiopharm International SA, part of Debiopharm Grouptm, a Swiss-based global biopharmaceutical company,...

08:00
LAUSANNE, Switzerland and ATLANTA, June 30, 2017 /PRNewswire/ -- Triptodurtm, (triptorelin) for extended release injectable suspension, has been shown to arrest or reverse the clinical signs of puberty with once every six-month intramuscular...

08:00
LAUSANNE, Suisse et ATLANTA, June 30, 2017 /PRNewswire/ -- Il a été démontré que Triptodur (triptoréline), suspension injectable à libération prolongée, pouvait enrayer ou inverser les signes cliniques de puberté grâce à l'administration d'une...


29 juin 2017

17:30
THOUSAND OAKS, Calif., June 29, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vectibix® (panitumumab) for patients with...

13:03
SAN DIEGO, June 29, 2017 /PRNewswire/ -- Evofem Biosciences, a biotechnology company focused on the development and commercialization of women's health products, today announced that its drug candidate, AMPHORA, being studied for contraception...

12:22
SAN DIEGO, June 29, 2017 /PRNewswire/ -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), announced today that the U.S. Food and Drug Administration (FDA) has authorized the Company's Investigational New Drug Application (IND) for...

10:31
SILVER SPRING, Md., June 29, 2017 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency's existing orphan designation request backlog and ensure continued timely response to all new...


28 juin 2017

18:36
AMSTERDAM, June 28, 2017 /PRNewswire/ -- Date de lancement fixée au premier trimestre 2018  Norgine B.V. a annoncé aujourd'hui qu'il a reçu l'acceptation de l'Agence américaine des produits alimentaires et médicamenteux (FDA) pour une demande...

16:00
AMSTERDAM, June 28, 2017 /PRNewswire/ -- Launch date set for first quarter 2018  Norgine B.V. today announced that it has received acceptance from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for PLENVU®* (NER1006)....

08:30
ORLANDO, Fla., June 28, 2017 /PRNewswire/ -- Profounda, Inc. ("Profounda") announced today that it has received the US Food and Drug Administration's Orphan Drug Designation for the use of miltefosine to...


27 juin 2017

09:15
PORT WASHINGTON, New York, June 27, 2017 /PRNewswire/ -- Equashield (http://www.equashield.com), a leading provider of Closed System Transfer Devices  (CSTDs) for hazardous drugs, announced today a new exclusive partnership for Belgium and...

08:00
AMSTERDAM, June 27, 2017 /PRNewswire/ -- Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market IntelliSpace Portal 9.0...

07:00
PETACH TIKVA, Israel, June 27, 2017 /PRNewswire/ -- OWC Pharmaceutical Research Corp. (OTCQB: OWCP) today announced that its wholly-owned, Israel-based subsidiary, One World Cannabis Ltd. (OWC), has filed a patent application with the United States...

03:05
PORT WASHINGTON, New York, June 27, 2017 /PRNewswire/ -- Equashield (http://www.equashield.com), un fournisseur incontournable de dispositifs de transfert en système clos  (CSTD) pour la manipulation de médicaments dangereux, a annoncé aujourd'hui...


26 juin 2017

14:37
TEL AVIV, Israel, June 26, 2017 /PRNewswire/ -- Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, announced today that it has begun the process of digitizing its New Drug Application (NDA) for...

12:01
BOCA RATON, Fla., June 26, 2017 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA Azacitidine for Injection, 100mg per vial, Single-Dose Vial, a generic version of Vidaza® by Celgene...

10:32
RARITAN, N.J., June 26, 2017 /PRNewswire/ -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that Ortho's VITROS® Immunodiagnostic Products Insulin Reagent and Calibrators have received 510(k) clearance from the...

09:00
TORONTO, June 26, 2017 /PRNewswire/ -- Last year at IFT's Annual Meeting & Food Expo, food safety company Agri-Neo introduced Neo-Pure, its validated food safety solution created specifically to control...

06:51
PHILADELPHIA, June 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 Hydrocodone Bitartrate and...


23 juin 2017

14:16
KING OF PRUSSIA, Pa., June 23, 2017 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced that the U.S. Food...

09:20
INDIANAPOLIS, June 23, 2017 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay, has received FDA PMA approval from the U.S. Food and...


22 juin 2017

17:47
EAST HANOVER, N.J., June 22, 2017 /PRNewswire/ -- Novartis today announced the US Food and Drug Administration (FDA) approval of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) to treat patients with metastatic non-small cell lung...

17:03
SILVER SPRING, Md., June 22, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema...

17:02
CARLSBAD, Calif., June 22, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing (NGS)-based test  that simultaneously screens tumor...

15:16
SAN DIEGO, June 22, 2017 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that the U.S. Food and Drug Administration (FDA) has...

13:54
LOS ANGELES, June 22, 2017 /PRNewswire/ -- The U.S. Food & Drug Administration has cleared as a Class II medical device Insulin Algorithms' decision-support software, which helps clinicians manage every type of insulin for diabetes treatment....

06:53
PHILADELPHIA, June 22, 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 Hydrocodone Bitartrate and...


21 juin 2017

11:22
BREA, Calif., June 21, 2017 /PRNewswire/ -- Beckman Coulter Diagnostics along with partner Diazyme Laboratories announces FDA clearance of a new procalcitonin (PCT) assay, an important tool for the management of bacterial infections and sepsis....

10:34
LITTLE SILVER, N.J., June 21, 2017 /PRNewswire/ -- Additive Orthopaedics, LLC., an orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D printed minimally-invasive, intramedullary Bunion Correction System,...

09:00
NESS ZIONA SCIENCE PARK, Israel, June 21, 2017 /PRNewswire/ -- Israeli biotechnology company Kadimastem (TASE: KDST) announced today that it had received approval from the IRB (Helsinki Committee) of the Hadassah Ein Kerem Hospital for the phase...


20 juin 2017

18:48
LEXINGTON, Massachusetts, June 20, 2017 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved MYDAYIS[TM] (mixed salts of a single-entity amphetamine product), a once-daily...

09:06
WAYNE, Pa., June 20, 2017 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for...

08:30
TAMPA, Fla., June 20, 2017 /PRNewswire/ -- Intezyne Technologies, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced that that the Office of Orphan Products Development of the Food and Drug Administration...

06:59
FRANKLIN LAKES, N.J., June 20, 2017 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that its new line of Snowden-Pencertm 3.0mm laparoscopic ergonomic take-apart instruments...


19 juin 2017

09:00
THOUSAND OAKS, Calif., June 19, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the XGEVA® (denosumab) supplemental Biologics License Application (sBLA) that seeks to...

07:07
ATLANTA, June 19, 2017 /PRNewswire/ -- Spine surgery offers a new lease on life for patients experiencing back pain and discomfort. With an estimated 450,000+ lumbar fusions performed each year in the United States, surgeons are familiar with...

06:53
PHILADELPHIA, June 19, 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 Niacin Extended-Release...


16 juin 2017

14:15
HORSHAM, Pa., June 16, 2017 /PRNewswire/ -- Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the immunotherapy DARZALEX® (daratumumab) in combination with pomalidomide and dexamethasone for the...


15 juin 2017

12:01
SILVER SPRING, Md., June 15, 2017 /PRNewswire-USNewswire/ -- It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory...

08:00
MARLBOROUGH, Mass., June 15, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for Cynosure's non-invasive body contouring...


14 juin 2017

09:53
QUÉBEC et MYRTLE BEACH, VA, le 14 juin 2017 /CNW Telbec/ - TSO3 inc. (TSX : TOS), une innovatrice dans le domaine de la stérilisation des instruments médicaux en milieu hospitalier, a annoncé aujourd'hui que la Société projette...

09:47
QUEBEC CITY, QC and MYRTLE BEACH, VA, June 14, 2017 /PRNewswire/ - TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company now plans to seek 510(k) clearance for its...


13 juin 2017

14:19
WASHINGTON, June 13, 2017 /PRNewswire-USNewswire/ -- The International Dairy Foods Association appreciates the Food and Drug Administration's (FDA) announced intention to extend the compliance dates for the new Nutrition Facts label and...

10:00
PLEASANTON, Calif., June 13, 2017 /PRNewswire/ -- Interson announced today they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market their SiMPLi Series ultrasound array probes for medical applications.  Interson...

09:00
BLACKSBURG, Va., June 13, 2017 /PRNewswire/ -- TECHLAB,® Inc., a leading developer and manufacturer of rapid, non-invasive diagnostic tests for gastrointestinal disease,...


12 juin 2017

04:05
Ongoing Expansion of Facility Furthers Commitment to Irish Manufacturing   SAN RAFAEL, California, June 12, 2017 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today The Food and Drug Administration (FDA) has approved a bulk...

01:30
Thermo Scientifictm CEDIA® Buprenorphine II Assay received FDA 510(k) clearance and CE Mark ATHENS, Greece, June 12, 2017 /PRNewswire/ -- EuroMedLab -- A new immunoassay for the specific detection of buprenorphine and its three major metabolites...

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