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News by subject: FDA

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21 january 2020

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 for OBI-999 for the treatment of Gastric Cancer. OBI-999 is a...


20 january 2020

11:00
Polaryx Therapeutics, a biotech company developing patient-friendly small molecule therapeutics for lysosomal storage disorders announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food...


19 january 2020

21:44
Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, Republic of Korea, announced that the Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA) has been cleared on...


16 january 2020

17:56
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic® (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack,...

08:30
ANI Pharmaceuticals, Inc. ("ANI") today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Potassium Citrate Extended-Release Tablets USP, 10 mEq and 15...


15 january 2020

13:00
UCB Canada Inc. announced today that Health Canada has approved CIMZIA® (certolizumab pegol) for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by...


14 january 2020

07:07
Astellas Pharma Canada, Inc., announced that Health Canada has approved the oral once-daily therapy XOSPATA (gilteritinib) for the treatment of adult patients with relapsed (disease that has returned) or...

07:00
Phagenesis Ltd., a pioneering leader in the treatment of dysphagia, is pleased to announce today that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Phagenyx System. The Phagenyx...

02:00
Phagenesis Ltd., a pioneering leader in the treatment of dysphagia, is pleased to announce today that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Phagenyx System. The Phagenyx...


13 january 2020

09:00
Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute...

09:00
Aidoc, the leading provider of AI solutions for radiologists, today announced that the US Food and Drug Administration (FDA) has cleared its AI solution for flagging Large-Vessel Occlusion (LVO) in head CTA scans, marking Aidoc's fourth FDA-cleared...

09:00
Opsens Inc. ("Opsens" or the "Company")   today announced 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to market its OptoWire III, a coronary pressure guidewire for physiological measurements such as Fractional Flow Reserve...

08:29
BioMarin Pharmaceutical Inc. , a pioneer in treatments for the rare disease Phenylketonuria (PKU) and in gene therapy clinical research, announced today that both the U.S. Food and Drug Administration (FDA) and the Medicines and Healthcare Products...

08:00
Spectra Medical Devices - Huons Co., Ltd. are proud to announce the FDA approval of their Abbreviated New Drug Application (ANDA) for Bupivacaine HCl with Dextrose USP, 0.75% / 8.25% in 2 mL ampules.   The product is now available along with...

07:00
Mereo BioPharma Group plc , "Mereo" or the "Company," and Oncologie, Inc. ("Oncologie") today announced a global license agreement (the "License Agreement") for the development and commercialization of navicixizumab, an anti-DLL4/VEGF bispecific...

06:52
Lannett Company, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory pathway, for Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL), the...

06:45
Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the Journal of Drugs in Dermatology (JDD) published positive results...


9 january 2020

15:52
Blueprint Medicines Corporation , a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has approved AYVAKITtm (avapritinib) for...

15:44
Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal...

10:00
Cutting Edge Spine, a leader in the development and commercialization of bioactive spinal solutions, today announced the 510(K) clearance and commercial launch of the latest addition to its bioactive portfolio of interbody systems, the EVOL®ha-DLIF...

08:00
Presage Biosciences, a biotechnology company pioneering a new cancer drug development approach using its CIVO®  intratumoral microdosing platform, announced today that the U.S. Food and Drug Administration (FDA) has approved its first Exploratory...

07:30
The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production and commercialization of radiopharmaceuticals, is announcing today that, following a successful U.S. Food and Drug Administration (FDA)...

07:00
MicroVention, Inc., a U.S. based subsidiary of Terumo and a global neurovascular company announced the FDA Premarket Approval (PMA) for the FRED® (Flow Re-Direction Endoluminal Device) device for the treatment of brain aneurysms.   The FRED® device...


8 january 2020

15:30
Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for MYCAMINE® (micafungin for injection) in support of the treatment of Candidemia, Acute Disseminated...

08:00
Colospan which develops novel solutions for colorectal surgery, announced today that the United States Food and Drug Administration (FDA) has approved the company's investigational device exemption (IDE) application. With this IDE approval in hand,...

07:59
AstraZeneca Canada today announced that Health Canada has approved Calquence® (acalabrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with chronic lymphocytic leukemia (CLL), as monotherapy or in...

07:00
Aruvant, a clinical-stage biopharmaceutical company focused on developing and commercializing transformative therapies for the treatment of severe blood disorders, today announced that the U.S. Food and Drug Administration has granted Rare Pediatric...

00:00
Spreadsheet Validation Latest Regulatory Developments and Best Practices An FDAnews Webinar Wednesday, Jan. 22, 2020, 1:30 p.m.-3:00 p.m. EST https://www.fdanews.com/spreadsheetvalidation What if one could perch on the shoulder of an expert on...


7 january 2020

10:04
Abbott  today announced U.S. Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott's HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid open heart surgery. The new, less...

07:00
Following the additional U.S. Food and Drug Administration (FDA) clearance for its Cryoablation Technology, IceCure Medical Ltd. , an Israeli medical device company, developers of a non-surgical Liquid Nitrogen (LN2) cryoablation technology to...


6 january 2020

09:05
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp® (insulin aspart injection) 100 u/mL for use as a new mealtime insulin option for children with diabetes.1 Fiasp® is the first and only fast-acting...

08:34
FreMon Scientific is pleased to announce the FDA has now cleared ZipThawtm for frozen plasma thawing as a Class II medical device. ZipThaw, used with the ZipSleevetm anti-contaminant disposable barrier, is the world's first dry and portable precision...

08:30
Emmes today announced that the U.S. Food and Drug Administration (FDA) has approved a prescription-only medical device used to estimate the weight of infants who are up to 90 days of age. The Mercy babyTAPE is a...


1 january 2020

19:01
WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, congratulates its partner OncoImmune on the U.S. Food and...


31 december 2019

13:00
Health Canada approval follows priority review for VascepaVascepa becomes the first and only HC-approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in the studied high-risk patients approved for...


30 december 2019

14:41
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, has received FDA approval for their generic version of Febuxostat 40mg and 80mg tablets.  The product is AB rated to the brand Uloric©,...

01:27
Foresee-X is a set of smart surgical glasses with functionality based on augmented and mixed reality technologies. This device was developed by SURGLASSES, also known as Taiwan Main Orthopaedic Biotechnology Co. Ltd., and has received IEC60601-1-2...


26 december 2019

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 for OBI-999 for the treatment of Pancreatic Cancer. OBI-999 is a first-in-class antibody...


23 december 2019

15:19
The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated...

15:13
Allergan plc today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for UBRELVYtm (ubrogepant) for the acute treatment of migraine with or without aura in adults. UBRELVYtm is the first and only...

14:46
The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Ubrelvy is not indicated for the preventive...

09:30
iotaMotion, Inc., an early-stage medical technology startup spun out of the University of Iowa's Otolaryngology Department, announced today that the company has filed a De Novo application seeking FDA authorization to market in the US its cochlear...

09:05
The U.S. Food and Drug Administration (FDA) has accepted SciTech Development's Investigational New Drug (IND) Application for ST-001 nanoFenretinide, an experimental treatment for T-cell non-Hodgkin's lymphoma (NHL). The...

08:05
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the U.S. Food and Drug Administration (FDA) approved DAYVIGOtm (lemborexant) 5 mg and 10 mg for the treatment of adult patients with insomnia, characterized by...

06:52
Lannett Company, Inc. today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Butalbital, Acetaminophen and Caffeine (BAC) Capsules, USP, 50mg/300mg/40mg...


21 december 2019

10:12
Dova Pharmaceuticals, Inc., a wholly owned subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobitm) has been granted Orphan Drug Designation[1] (ODD) by the US Food and Drug Administration (FDA) for avatrombopag for the potential treament of...


20 december 2019

15:57
e5 Pharma, LLC., today announced the U.S. launch of Diazoxide, USP Oral Suspension, the first generic version of the reference listed drug, Proglycem®. e5 Pharma received final approval from the U.S. Food and Drug Administration (FDA) for its...

15:00
VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering and improving the health economics of care, today announced it has received US Food and Drug Administration (FDA) approval of GENOSYL®...

14:56
Today, the U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other...


19 december 2019

16:44
Amgen and Allergan plc.  today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan® (rituximab). Amgen and Allergan are collaborating on four...

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