Le Lézard

News by subject: FDA

9 october 2018

11:15
Vapotherm, Inc. (Vapotherm), a leader in advanced respiratory technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Vapotherm's latest version of the Precision Flow® product, the Precision Flow Hi-VNItm system, a...


8 october 2018

07:00
Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the...


5 october 2018

17:08
The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years....

16:00
Coordination Pharmaceuticals, Inc. (CPI), a privately held and clinical-stage biopharmaceutical company focused on nanotechnology-based cancer immunotherapy, announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's...

14:30
Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Roflumilast Tablets, 500mcg, generic for Daliresp® Tablets by AstraZeneca...

13:48
The U.S. Food and Drug Administration today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first...

11:01
Today, the Medical Technology business group of ZEISS announced the FDA Premarket Approval (PMA) for ReLEx® SMILE® PMA expanding myopia treatment to patients with astigmatism. The PMA also provides for a small entry incision to be made, allowing the...

08:35
EAS Consulting Group is honored to announce that Dean Cirotta, EAS President and COO, was an invited key speaker to the September 29, 2018 Fourth Session of the SIDS DOCK Assembly ? the Sustainable Energy and Climate Resilience Organization, at the...


4 october 2018

07:30
Allergan plc today announced that the CoolSculpting® treatment received FDA clearance to treat the submandibular area. In addition, the FDA clearance was expanded to include patients with a BMI of up to 46.2 when treating the submental and...


3 october 2018

11:06
CarboFix in Orthopedics LLC., has announced today that the U.S. Food and Drug Administration (FDA) has cleared its CarboClear® Carbon Fiber Transverse Connectors to be used in conjunction with its Carbon Fiber Pedicle Screw System, a novel device to...

08:00
PARI Pharma GmbH, a company focused on the development and commercialization of advanced aerosol delivery systems based on eFlow Technology, announces approval of its optimized eFlow technology nebulizer LAMIRAtm together with Insmed's ARIKAYCE®...


2 october 2018

09:00
Processa Pharmaceuticals, Inc. , a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have high unmet medical need conditions, announced today that the U.S. Food and Drug...

08:07
Today QOL Medical, LLC announced that the U.S. Food and Drug Administration (FDA) has approved the company's wholly owned manufacturing facility in Clearwater, Florida to manufacture sacrosidase, the drug substance used to make Sucraid® (sacrosidase)...

06:07
QOL Medical, LLC today announced that the U.S. Food and Drug Administration (FDA) has approved its new, state-of-the-art manufacturing facility in Florida. The supply of Sucraid® (sacrosidase) Oral Solution has been restored. QOL Medical, LLC is now...


1 october 2018

09:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination...

08:32
Infinity Pharmaceuticals, Inc. announced today that it earned a $22 million payment from Verastem Oncology under the license agreement between the Company and Verastem for COPIKTRA (duvelisib).  The payment was earned upon the approval by the U.S....


29 september 2018

23:00
Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops high quality drugs, announced yesterday that its IND application for IBI-188, a fully human anti-CD47 monoclonal antibody (mAb) drug candidate, has...


28 september 2018

17:22
The U.S. Food and Drug Administration today approved a new drug, Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of...

16:51
The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for...

16:39
Libtayo is the third anti-PD-1 approved in the U.S. CSCC is the second most common skin cancer in the U.S. Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo®...

16:29
Today the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a...

14:54
Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug FYCOMPA® (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of...

08:00
TransThera Biosciences Co. Ltd, announced today that the company received FDA IND application approval for TT-00420, a novel small molecule investigational drug targeting Triple-Negative Breast Cancer (TNBC). TT-00420 is a selectively clustered...


27 september 2018

19:52
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Emgalitytm (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults.1 Emgality offers a once-monthly,...

16:05
Sandoz Inc. today announced that the US Food and Drug Administration has approved SYMJEPItm (epinephrine) 0.15 mg Injection for the emergency treatment of allergic reactions in children. Sandoz will distribute and commercialize SYMJEPItm...

12:49
HighTide Therapeutics Inc., a globally focused clinical-stage biopharmaceutical company, announced that the U.S. FDA has granted Fast Track Designation to its investigational new drug, HTD1801, for the treatment of patients with primary sclerosing...

08:00
Profounda, Inc. ("Profounda") announced today that it has received the US Food and Drug Administration's Competitive Generic Therapy (CGT) Designation for the planned future ANDA filing of Minocycline Hydrochloride Microspheres, 1 mg, pursuant to...


26 september 2018

09:59
IDx, the company that has developed the first and only FDA-cleared autonomous AI diagnostic system, has secured significant venture capital funding to accelerate market adoption and further develop additional diagnostic systems for its AI platform....

08:38
OrthoXeltm is a specialist orthopaedic trauma company, using innovative engineering design to evolve truly next generation fracture fixation devices. OrthoXeltm is delighted to announce that the new Apex Femoral Nailing System has been granted US FDA...

07:30
Allergan plc , a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for VRAYLAR® (cariprazine), seeking to expand the...

06:00
INSIGHTEC®,a global medical technology innovator of incisionless surgery, today announced that the U.S. Food and Drug Administration (FDA) has approved Exablate Neurotm compatibility for the state-of-the-art MRI Scanners Magnetom Skyra, Prisma and...

05:00
Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® X Lateral Interbody Fusion System. Tesera X is the latest...

02:00
Aronora Inc., a clinical stage biotechnology company developing first-in-class treatments for life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for proCase (E-WE thrombin,...


25 september 2018

06:30
The privately-owned company, MT.DERM GmbH, Berlin, Germany, a manufacturer of medical microneedling, micropigmentation and tattoo equipment is excited to announce its expansion into the US market of its medical microneedling device, Exceed under the...


24 september 2018

08:00
Alnylam Pharmaceuticals, Inc. , the leading RNA interference (RNAi) therapeutics company, announced today that Health Canada has granted Priority Review status to patisiran. Priority review is granted to regulatory filings in Canada intended for new...

06:45
Today, Boston Scientific announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application to market the Eluviatm Drug-Eluting Vascular Stent System, specifically developed for the treatment of...


21 september 2018

13:30
Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug...


20 september 2018

17:05
Vanda Pharmaceuticals Inc. (Vanda) today announced that a HETLIOZ® patent, number 10,071,977 ('977 patent), is now listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly...

05:00
Leica Microsystems received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its augmented reality GLOW800 surgical fluorescence for vascular neurosurgery. In combination with ICG (Indocyanine Green), GLOW800 allows...


19 september 2018

05:00
OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL). OBI-3424 is a...

01:00
Additional clinical trial data for prophylaxis of HAE requested Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug...


18 september 2018

16:30
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of erdafitinib for the treatment of patients with locally...

15:13
Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to...

08:45
Healcerion today announced the SONON 300L will be unveiled to the US market with live demos at booth #722 in the New Exhibitor Pavilion at FMX Family Medicine Experience Show 2018, October 9-13, Ernest N. Morial Convention Center, New Orleans, LA....

08:10
Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first filter-based Integrated Embolic Protection (IEP) device, the Paladin® Carotid PTA Balloon System. Contego Medical is...

08:05
FDA & USDA announced they have approved Phageguard-E as a "GRAS" (Generally Recognized as Safe) food processing aid against E.coli O157. The new product consists of natural phages against E.coli and is produced by Micreos of The Netherlands. The...

07:00
Bayer Inc. has announced that Health Canada has approved XARELTO® (rivaroxaban) film-coated tablet (2.5 mg), in combination with 75 mg ? 100 mg acetylsalicylic acid (ASA)* for the prevention of stroke, myocardial infarction and cardiovascular death,...


17 september 2018

10:35
Oramed Pharmaceuticals Inc. (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New...

09:00
WAT Medical's innovative technology to treat all primary headaches, HeadaTerm, received its FDA clearance in September 2018. This product, already approved by CE, HC, and now FDA, has been distributed in over 20 countries around the world. It has now...

08:00
Halozyme Therapeutics, Inc. today announced that Roche has received approval from Health Canada for a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) for the treatment of patients with HER2-positive breast cancer. This is a...