Le Lézard

News by subject: FDA

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21 june 2019

17:40
Palatin Technologies, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval of AMAG Pharmaceuticals, Inc.'s New Drug Application (NDA) for Vyleesitm (bremelanotide injection), a melanocortin receptor...

17:13
The U.S. Food and Drug Administration today approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. "There are women who, for no known reason, have...

13:27
The U.S. Food and Drug Administration today expanded the indication for Symdeko (a combination of tezacaftor/ivacaftor) tablets for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations. Last...

07:30
Allergan plc today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental biologics application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity....


20 june 2019

10:30
ANI Pharmaceuticals, Inc. ("ANI") today announced that it has received FDA approval of its Prior Approval Supplement for Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 ml, indicated for the treatment of various infections.  ANI intends to...

07:30
Edesa Biotech, Inc. , a clinical-stage biopharmaceutical company, reported today that the U.S. Food and Drug Administration has notified the company that it may proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which Edesa is...

07:17
Camurus , a commercial stage biopharmaceutical company specializing in long-acting medicines for severe and chronic disorders, announced today the acceptance by the US Food and Drug Administration (FDA) of an Investigational New Drug...


19 june 2019

09:18
ReNetX Bio, Inc., a leading biotechnology company committed to reversing disease and damage for patients suffering from central nervous system disorders, has announced that the U.S. Food and Drug Administration (FDA) has allowed the Company's...

06:00
CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, today announced that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for...


18 june 2019

14:15
EMulate Therapeutics, Inc., a clinical-stage therapeutic device company developing non-invasive treatments for cancers and other serious diseases, announced it has received notice that the US Food and Drug Administration (FDA) accepted for filing the...


17 june 2019

17:41
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Victoza® (liraglutide) injection to lower blood sugar along with diet and exercise in children and adolescents aged 10-17 years with...

16:16
Eiger BioPharmaceuticals, Inc. , focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for...

15:26
The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric...

10:58
Zebra Medical Vision (https://www.zebra-med.com/), the deep learning medical imaging analytics company, announces today that it has received its third FDA 510(k) clearance for the company's HealthICH product - an AI alert for intracranial hemorrhage...

09:15
Bio-Techne today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough...

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...

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