Le Lézard

News by subject: FDA

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Today

16:20
Today, the U.S. Food and Drug Administration approved Rukobia (fostemsavir), a new type of antiretroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other...

11:47
Camargo Pharmaceutical Services, LLC, congratulates Chiasma, Inc. on obtaining approval from the US Food and Drug Administration for MYCAPSSA® (octreotide) capsules. MYCAPSSA is the first and only oral somatostatin analog (SSA) approved by the FDA....

05:00
Textile innovator HeiQ's antiviral textile technology, HeiQ Viroblock NPJ03, has been certified as safe and sustainable as all its ingredients are cosmetic grade, bio-based, and recycled....


1 july 2020

14:34
Gravity Diagnostics, a CLIA laboratory headquartered in Covington, Kentucky, today announced the U.S. Food and Drug Administration (FDA) has granted an update to their Emergency Use Authorization (EUA) to include use of nasal swab specimens that are...

06:36
Golden Biotechnology Corp. (GoldenBiotech, 4132.TWO), a leading Taiwanese biopharmaceutical company, announced that the FDA approved its investigational new drug (IND) application for a Phase II clinical trial of Antroquinonol (Hocena®) on COVID-19...

06:10
InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, announced today that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SCoV-2 Detect IgM ELISA...

06:05
Engage Surgical, a privately held orthopedic implant company, announces FDA 510(k) clearance of the only cementless partial knee system available in the USA....

03:00
ISA Pharmaceuticals B.V., a clinical-stage company dedicated to developing rationally designed immunotherapeutics for oncology and infectious disease, today announced that it received Orphan Drug Designation from the Food and Drug Administration...

02:21
CARAG AG, a privately-held Swiss medical device development company, today announced receiving U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for its Carag Bioresorbable Septal Occluder (CBSO). The CE-marked...


30 june 2020

18:45
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for...

12:07
LivsMed Inc. recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the new ArtiSentialtm Bipolar Maryland Dissectors. This completes its energy product line, which also includes the Bipolar...

10:00
Imaging Artificial Intelligence (AI) provider Qure.ai announced its first US FDA 510(k) clearance for its head CT scan product 'qER'. The US Food and Drug Administration's decision covers four critical abnormalities identified by Qure.ai's emergency...

09:40
CVRx, Inc., a private medical device company, announced today that its BeAT-HF phase III randomized clinical trial results were published in the Journal of the American College of Cardiology ("JACC"). Results from the trial were used to obtain...

09:15
IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received expanded U.S. Food and Drug Administration (FDA 510k) clearance for its Photodynamic Bone Stabilization System...


29 june 2020

23:14
Alterity Therapeutics ("Alterity" or "the Company") is pleased to announce that it has received guidance from the US Food and Drug Administration (FDA) in relation to the development pathway for ATH434 (previously PBT434), the company's lead...

16:05
ReNeuron Group plc (AIM:RENE), a global leader in the development of cell-based therapeutics, is pleased to announce further positive long-term data from the ongoing Phase 2a clinical trial of its hRPC stem cell therapy candidate in retinitis...

15:33
Today, the U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient...

13:10
Today, the U.S. Food and Drug Administration approved Phesgo?a combination of pertuzumab, trastuzumab and hyaluronidase?zzxf?for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the...

12:54
Halozyme Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Roche's Phesgotm (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, a fixed-dose combination (FDC) of Perjeta® and Herceptin® with...

08:00
Beckman Coulter today announced that its Access SARS-CoV-2 IgG assay has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA). Beckman Coulter has already shipped tests to more than 400 hospitals, clinics and...


25 june 2020

23:05
Zogenix, Inc. , a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved FINTEPLA® (fenfluramine) oral solution, CIV for the treatment of seizures associated with...

19:50
The U.S. Food and Drug Administration today approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare...

11:00
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antibody test distributed by Virality Diagnostics LLC, manufactured by Biohit (Hefei). This test, authorized on June 18th, 2020, is a rapid...


24 june 2020

09:00
A Korean molecular diagnostic company, Gencurix, Inc., has announced that they have received U.S. Food and Drug Administration (FDA)'s Emergency Use Authorization (EUA) for its GenePro SARS-CoV-2 Test....


23 june 2020

09:00
Reneo Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate, REN001, for the treatment of primary mitochondrial...

08:21
Companion Medical, manufacturers of InPen, the only FDA-cleared smart insulin pen system, today announced that they received FDA expanded clearance for all ages* to use the InPen System. "We are excited that we can help younger children and even...

08:00
preCARDIA, Inc., has announced that the company's catheter based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) has been designated for the Breakthrough Devices Program by the U.S. Food and Drug...

07:00
Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int'l., (Holdings) Inc., announces that the U.S. Food and Drug Administration (FDA) has granted its application...


22 june 2020

14:15
Frozen Wheels, a leading distributor of food and PPE, is announcing the opening of an office in Thailand in response to the growing demand for powder-free nitrile examination gloves. "The COVID-19 pandemic has caused a challenge for healthcare...

08:00
Allergan, an AbbVie company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA) to expand the BOTOX® prescribing information for the treatment of signs and...


19 june 2020

13:44
Single-dose (300 mg) pre-filled pen provides additional administration option to adults and adolescents who are prescribed Dupixent 300 mg pre-filled pen expected to be available third quarter of 2020 Regeneron Pharmaceuticals, Inc. and Sanofi today...

10:20
Roche (SIX: RO, ROG;OTCQX: RHHBF) today announced U.S. Food and Drug Administration (FDA) approval of the cobas® EZH2 Mutation Test as a companion diagnostic for TAZVERIKtm(tazemetostat), developed by Epizyme, Inc. This molecular test detects...


18 june 2020

16:20
Millions of patients across the United States suffer from Type 2 diabetes, and one-quarter or more of those patients also have kidney disease, making diabetic kidney disease (DKD) one of the largest causes for morbidity and mortality in the country....

14:19
Aesculap Implant Systems, LLC today announced that it has been five years since the organization received FDA approval to market the activL® Artificial Disc in the United States. In the last five years, the data behind lumbar arthroplasty along with...

13:45
Today, the U.S. Food and Drug Administration approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened...

09:56
icotec ag announces that the KONG®-TL and the KONG®-C vertebral body replacement systems with the unique Titaniumcoating (Ti-iT®) receive FDA 510(k) clearance in the United States and CE approval in Europe ....

09:48
As previously disclosed, the US authority FDA has approved SpectraCure's new and revised study protocol for the clinical study on patients with recurrent prostate cancer. The protocol has also been approved by the UK and Canadian authorities. The new...

09:19
Aethlon Medical, Inc. , a therapeutic medical device and technology company focused on unmet needs in viral diseases, oncology and inflammation, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplement to the...

09:00
Almirall LLC today announced that the FDA approved an important update to the Seysara® label stating that P. acnes strains displayed a low propensity for the development of resistance to sarecycline. This information is included in the Microbiology...

09:00
Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, today announced that the U.S. Food and Drug...


17 june 2020

23:07
Protagonist Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for PTG-300 for the treatment of polycythemia vera. PTG-300 is an injectable synthetic peptide mimetic of the natural...

17:44
Naviswiss AG, a medical technology company based in Denver, Colorado, with headquarters in Brugg, Switzerland, receives FDA Clearance on June 10, 2020, for their new navigation technology for hip replacement surgery. The clearance includes primary...

08:34
Enexor Health Systems announced today that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization for the immediate delivery and use of a new ventilator, the X-VENT. Enexor will start delivering ventilators to...


16 june 2020

22:20
Novartis, a leader in rheumatology and immuno-dermatology, today announced that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming...

15:45
Valeo Pharma Inc. ("Valeo" or the "Company"), a Canadian specialty pharmaceutical company,  announced today that it has received approval for its Abbreviated New Drug Application ("ANDA") from the U.S. Food and Drug Administration ("FDA") for...

12:00
Technical Safety Services (TSS) announced today that the U.S. Food and Drug Administration has issued an emergency use authorization (EUA) using vaporized hydrogen peroxide (VHP) to decontaminate compatible N95 respirators in the United States for...

10:00
Ziosoft, a pioneer in 3D/4D medical AI visualization, announced it has received a 510(k) clearance from the Food and Drug Administration (FDA) for Computed Tomography (CT) Dual Energy Analysis software on the company's flagship Ziostation2 system....

09:38
- Lurbinectedin is approved under "Accelerated Approval" based on overall response rate and duration of response demonstrated in an open-label, monotherapy clinical trial. - The anti-tumor compound lurbinectedin will be marketed under the brand name...

09:00
CLEW announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the company's ICU solution. With CLEWICU healthcare providers use predictive screening information to help identify patients with...


15 june 2020

22:21
The U.S. Food and Drug Administration (FDA) has approved Lyumjevtm (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company's new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type...

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