Le Lézard

News by subject: FDA

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Today

07:04
Cochlear Limited , the global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration's (FDA) approval of the new Cochleartm Nucleus® Profiletm Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's...


14 june 2019

07:30
Ampio Pharmaceuticals, Inc. announced today that it received FDA approval of the Company's special protocol assessment (SPA) of a clinical protocol titled "A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an...


13 june 2019

19:13
Amgen and Allergan plc today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTItm (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of...


12 june 2019

10:46
eMurmur® announced today that its flagship "eMurmur ID" solution has received the CE mark certification. Accreditation is an important part of the eMurmur business, which now carries the quality management certification ISO 13485:2016 and the EC...

09:00
Bolder BioTechnology, Inc. announced today that its long-acting IL-11 analog, BBT-059, has received Orphan Drug designation from the Food and Drug Administration for treatment of Acute Radiation Syndrome (ARS). Orphan Drug designation is reserved for...


11 june 2019

16:05
Aratana Therapeutics, Inc. , a pet therapeutics company focused on the development and commercialization of innovative therapeutics for dogs and cats, today announced the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM)...

14:32
EmCyte, is proud to announce that it has received FDA 510(k) clearance for its PureBMC® Supraphysiologic Concentrating System. The system's 510(k) number is K183205 and is cleared for the safe and rapid preparation of platelet concentrate and cell...

10:00
CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced FDA 510(k) clearance for the Cortm PATCH.  The Cortm PATCH is indicated for epicardial tissue support and repair in...

09:00
Aidoc, the leading provider of AI solutions for radiologists, today announced that the Food and Drug Administration (FDA) has cleared the world's first AI solution for triage of cervical spine fractures. The latest 510(k) clearance is Aidoc's third,...


10 june 2019

11:54
Today, the U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as "BR"), to treat adult patients with...


7 june 2019

13:31
PTC Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Emflaza® (deflazacort) to expand its labeling to include patients with Duchenne muscular...


6 june 2019

11:19
Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced today that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Slyndtm (pronounced "slind") containing drospirenone 4 mg, an...

11:07
Akonni Biosystems Inc. announced today that the US Food and Drug Administration (FDA) has provided 510(k) clearance for its TruDiagnosis® System. With this approval, Akonni is poised to enter the $8B molecular diagnostics market. The TruDiagnosis®...


5 june 2019

15:00
Duchesnay Inc., a pharmaceutical company specializing in women's health, is pleased to announce the publication of a study showing improvements in vulvovaginal health with ospemifene as assessed by prospective vulvar-vestibular photography and other...

07:27
U Deliver Medical, LLC announced they have received Food and Drug Administration (FDA) 510(k) regulatory clearance for The bFedtm System tube feeding delivery products (Bolinktm tubing), to now be available to consumers without a prescription. This...

04:05
Brain Sentinel, Inc., manufacturer of the first FDA-cleared portable seizure monitoring and alerting technology utilizing surface electromyography (sEMG), announced that its SPEAC® System has received a new 510(k) clearance of expanded indications...


4 june 2019

21:01
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality® (galcanezumab-gnlm) injection (300 mg) for the treatment of episodic cluster headache in adults.1 Emgality is an innovative therapeutic...

16:50
The U.S. Food and Drug Administration today approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults. "Emgality provides patients with the first FDA-approved...

16:30
ReWalk Robotics, Ltd.  ("ReWalk" or the "Company"), a leading manufacturer of robotic medical devices for individuals with lower limb disabilities, announced today that the U.S. Food and Drug Administration ("FDA") has cleared the Company's ReStore...

12:42
Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Ti3Z...

08:50
W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration's (FDA's) premarket approval (PMA) of the GORE® CARDIOFORM ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs). The FDA approval was...

08:00
Biosight Ltd., a pharmaceutical development company focused on the development of novel oncology therapeutics, announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to BST-236, an investigational...


3 june 2019

15:25
The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia...

03:00
Nouscom, an immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, announced today that its Investigational New Drug (IND) application for the first clinical trial of its lead candidate NOUS-209 has been cleared...


31 may 2019

23:18
Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460) the largest cardio-cerebral vascular ("CCV") drug manufacturer in China's prescription drug market, announced that the Group has completed the post-launch clinical trials of "Cinepazide Maleate...

09:00
WAT Medical, a company that develops safe, effective, and user-friendly wearable medical products, recently announced that HeadaTerm, its migraine treatment product, has received official clearance from TGA Australia. With a team of devoted staff...


30 may 2019

08:00
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for...


29 may 2019

09:00
BioTheryX, Inc. ("BioTheryX"), a biotechnology company creating new classes of drugs based on multi-kinase inhibition and targeted protein degradation, today announced that the U.S. Food and Drug Administration ("FDA") has cleared BioTheryX's...

07:00
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the 510(k) clearance of QUANTA Flash® Rheumatoid Factor (RF) IgM and QUANTA Flash RF IgA assays by the US Food...

07:00
Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for testing throat and rectal specimens with its Xpert® CT/NG test. The test provides fast and accurate molecular detection of chlamydia and...

05:00
Leica Biosystems, the global leader in pathology workflow solutions, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Aperio AT2 DX System for clinical diagnosis in the U.S....


28 may 2019

22:00
Siesta Medical, Inc. (Private), a leading provider of minimally invasive implants and tools for obstructive sleep apnea (OSA), announced FDA clearance for expanded indications for its Encoretm System. The Encore System, used to the perform AIRLIFTtm...

10:19
Soliton, Inc., ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), today announced that it has...

09:10
It was a very significant week for Novadoz Pharmaceuticals, the U.S sales & marketing affiliate of  The MSN Group (MSN) based in Hyderabad, India.  The company was granted FDA approval to market Solifenacin Succinate tablets, their generic version of...

08:30
Theranica, a bio-medical technology company developing advanced electroceuticals for migraine and other pain disorders, announced today that the U.S. Food and Drug Administration (FDA) granted a De Novo request for its smartphone-controlled...

08:00
True Diagnostics, Inc. (True), a leading company for Point of Care Answers, announced today that its VeriCleartm Digital Early Result Pregnancy Test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for...

07:30
Allergan plc  and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for VRAYLAR® (cariprazine) for expanded use to treat depressive episodes associated with...


24 may 2019

18:14
The Muscular Dystrophy Association (MDA) today celebrated the decision by the U.S. Food and Drug Administration (FDA) to grant approval of Zolgensma (onasemnogene abeparvovac-xioi), the first gene therapy for a neuromuscular disease. Zolgensma is a...

16:51
Novartis today announced the US Food and Drug Administration (FDA) has approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal...

14:45
Today, the U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human...

13:14
REGENXBIO Inc. , a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the first U.S. Food and Drug Administration...

13:09
AveXis, a Novartis company, today announced the US Food and Drug Administration (FDA) has approved Zolgensma® (onasemnogene abeparvovac-xioi) for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with...

12:34
The U.S. Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading...

08:00
Kelyniam Global (KLYG), a maker of custom cranial and craniofacial implants, announced today that it has received premarket approval from the Food and Drug Administration (FDA) for a new 510(k) application that allows for unique modifications to...


23 may 2019

21:33
THINK Surgical, Inc. ("THINK") announces completion of enrollment for the U.S. investigational clinical study and submission of the 510(k) to obtain clearance from FDA to market its active robot, TSolution One®, for use in total knee replacement...

14:50
Today, the U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of...

10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) 510(k) clearance for the cobas® TV/MG test for use on the cobas® 6800/8800 Systems for the detection of Trichomonas vaginalis (TV) and/or Mycoplasma genitalium...


22 may 2019

08:00
EpiBone, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted its Investigational New Drug (IND) clearance to proceed with a Phase 1/2 clinical trial of its lead bone product EpiBone-Craniomaxillofacial (EB-CMF), as a...

06:00
Mayne Pharma Group Limited is pleased to announce that the US Food and Drug Administration (FDA) has approved SORILUX® (calcipotriene) Foam, 0.005% in adolescents. SORILUX is now approved for treating plaque psoriasis of the scalp and body in...


21 may 2019

12:32
Today, healthcare innovation startup, NightWare, Inc., a privately-held digital therapeutics for mental health company, has received Breakthrough Status designation from the U.S. Food and Drug Administration (FDA). Nightware's lead product,...

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