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Domenica 27 Novembre 2022
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Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with Newly Diagnosed FLT3-ITD Positive AML

SAN DIEGO, Oct. 24, 2022 /PRNewswire/ -- Invivoscribe is pleased to announce that they have filed a supplemental Pre-Market Approval (sPMA) submission with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) for the use of the LeukoStrat® CDx FLT3 Mutation Assay as the companion diagnostic for Daiichi Sankyo's investigational drug quizartinib. The assay is used for the identification of newly diagnosed acute myeloid leukemia (AML) patients that have the F...

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FDA Approves Taiho's LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

PRINCETON, N.J., Sept. 30, 2022 /PRNewswire/ -- Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved LYTGOBI® tablets for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

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MedAlliance SELUTION SLR Receives Second FDA IDE Approval

GENEVA, Aug. 10, 2022 /PRNewswire/ -- SELUTION SLR™, MedAlliance's novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA).

Covid, Usa: da Fda via libera a vaccino Novavax in over 18

Via libera negli Usa al vaccino anti-Covid adiuvato di Novavax per le persone con età dai 18 anni in su. La Food and Drug Administration (Fda) ha rilasciato un'autorizzazione all'uso di emergenza (Eua) per il prodotto scudo che utilizza la tecnologia delle proteine ricombinanti. La sua autorizzazione sottolinea il commissario della Fda, Robert M. Califf, "amplia le opzioni vaccinali disponibili per la prevenzione di Covid, compresi gli esiti più gravi che possono verificarsi, come il ricovero e l...

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FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older

GAITHERSBURG, Md., June 7, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals age...

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MedAlliance's SELUTION SLR drug-eluting balloon (DEB) receives FDA investigational device exemption (IDE) approval, making it the first limus DEB to be available to US patients

GENEVA, May 30, 2022 /PRNewswire/ -- The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) granted "breakthrough device designation" by the FDA on March 4, 2019 and further in September 25, 2019 for below-the-knee (BTK) indications in peripheral artery disease.

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SIFI RECEIVES FAVORABLE FEEDBACK FROM THE US FDA ON AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS

CATANIA, Italy, May 16, 2022 /PRNewswire/ -- SIFI S.p.A. ("SIFI" or the "Company"), a leading international ophthalmic company headquartered in Italy, announced today that it received favorable and supportive feedback from the United States Food and Drug Administration ("FDA") through a 'Type B' meeting held in early May regarding its potential regulatory application of AKANTIOR® (polihexanide) for the treatment of acanthamoeba keratitis ("AK"). The outcome of the FDA meeting supports the Company...

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FDA Approves Alymsys® (bevacizumab-maly), a Biosimilar of Bevacizumab developed by mAbxience

MIAMI, May 2, 2022 /PRNewswire/ -- Brand Institute is proud to announce its successful partnership with mAbxience developing the brand name ALYMSYS®, under which the biosimilar approved by the Food and Drug Administration (FDA) on April 13, 2022 will be marketed by Amneal Pharmaceuticals LLC. This biosimilar represents the third bevacizumab approved in the U.S.

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FDA Approves Direct Biologics to Proceed with a Landmark Phase 3 Acute Respiratory Distress Syndrome (ARDS) Trial

AUSTIN, Texas, April 26, 2022 /PRNewswire/ -- Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV company to receive FDA Phase 3 approval for an Investigational New Drug (IND) i...

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FDA granted CMG901 Fast Track Designation for unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies

CHENGDU, China, April 20, 2022 /PRNewswire/ -- Keymed Biosciences (2162.HK) announced that the U.S. Food and Drug Administration (FDA) granted CMG901 Fast Track Designation as monotherapy for the treatment of unresectable or metastatic gastric and gastroesophageal junction cancer which have relapsed and/or are refractory to approved therapies. This is another milestone after CMG901 received Orphan-drug Designation from the FDA.

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CMG901 for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma was granted the Orphan-drug Designation by the Food and Drug Administration of the United States

CHENGDU, China, April 12, 2022 /PRNewswire/ -- Keymed Biosciences (2162.HK) announced that its new drug candidate CMG901 (the "Claudin 18.2 antibody drug conjugates") for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma has been granted the Orphan-drug Designation by the Food and Drug Administration of the United States (the "FDA") recently. Previously, in March 2021, the Company received the clinical trial application approval of CMG901 from the FDA for the clinical t...

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Triastek Receives FDA IND Clearance for 3D Printed Product of Blockbuster Molecule

NANJING, China, April 7, 2022 /PRNewswire/ -- Triastek, Inc. ("Triastek") recently announced that the United States Food and Drug Administration (FDA) has granted permission to begin clinical studies of its Investigational New Drug (IND) 505(b)(2) application for a 3D printed drug product – T20.  It is Triastek's second product receiving IND clearance from the FDA.

Nyt, Fda potrebbe dare ok a quarta dose per over 50

L'amministrazione Biden sta pensando al secondo booster di vaccino Pfizer-BionTech o Moderna contro Covid-19 per la popolazione dai 50 anni in su. La Food and Drug Administration, l'ente regolatorio statunitense, potrebbe autorizzare la quarta dose per questa fascia d'età in questi giorni, secondo fonti vicine alla questione. Lo rivela il 'New York Times'.

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