XTalks

JANUARY 9, 2023

recently announced in a press release that Sunlenca (lenacapavir) received approval from the US Food and Drug Administration (FDA) for use as a twice-yearly treatment option for people living with multi-drug resistant HIV (human immunodeficiency virus). Gilead Sciences, Inc.

FDA Approval 98

FDA Approval Drugs In-Vitro Clinical Trials 98

pharmaphorum

JANUARY 17, 2022

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Central nervous system-controlled behaviour, such as food intake, is notoriously difficult to explore in vitro.

FDA Approval 123

FDA Approval In-Vitro Regulation Hormones 123

XTalks

NOVEMBER 15, 2023

The FDA says chikungunya is an emerging global health threat as at least 5 million cases of chikungunya virus infection have been reported in the last 15 years. Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options.”

FDA Approval 59

FDA Approval Vaccine Vaccination In-Vitro 59

The Pharma Data

AUGUST 27, 2020

The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies.

FDA Approval 52

FDA Approval Genome Genomics Gene 52

Delveinsight

SEPTEMBER 30, 2021

The company has also filed for the US Food and Drug Administration (FDA) for clearance. According to DelveInsight’s analysis , the approval of RETINA-AI Galaxy software will be a game-changer in the annual examination of the eye in diabetic patients. Paige obtains first-ever FDA approval for AI product in digital pathology.

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FDA Approval Marketing In-Vitro Drugs 83

The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. ” The findings published today (Feb. ” The findings published today (Feb.

FDA Approval 52

FDA Approval Drugs Protein In-Vitro 52

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

XTalks

AUGUST 9, 2023

a leader in developing therapeutic solutions for common diseases with limited treatment alternatives, has secured approval from the US Food and Drug Administration (FDA) for its drug, Xdemvy (lotilaner ophthalmic solution) 0.25%. California-based Tarsus Pharmaceuticals Inc., What Is Demodex Blepharitis?

FDA Approval 98

FDA Approval In-Vitro Trials Bacteria 98

The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS –(BUSINESS WIRE)–Oct.

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FDA Approval Trials Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 6, 2020

This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. months, not reached). 2 The most common adverse reactions (?

FDA Approval 52

FDA Approval Medicine In-Vitro Genetics 52

The Pharma Data

SEPTEMBER 15, 2020

New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs. Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S.

FDA Approval 52

FDA Approval In-Vitro DNA Medicine 52

XTalks

DECEMBER 28, 2023

XTALKS WEBINAR: Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users Live and On-Demand: Tuesday, January 9, 2024, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn how the new In Vitro Diagnostic Regulation (IVDR) impacts manufacturers and users of diagnostic devices.

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Trials Clinical Trials Clinical Trials Antibody 97

The Pharma Data

AUGUST 31, 2020

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S.

FDA Approval 52

FDA Approval In-Vitro Antibody Medicine 52

The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

FDA Approval 52

FDA Approval Bacteria Clinical Trials Clinical Trials 52

The Pharma Data

MAY 31, 2022

The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. Jude Children’s Research Hospital.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 52

The Pharma Data

JANUARY 6, 2021

SK Chemicals has shared their expertise in these diseases and validated the predicted targets and compounds through in vitro and in vivo studies. The compound in the patent was discovered by Standigm Insight , an AI-aided drug-repurposing platform. This patent is just the beginning of many results expected from our extended collaboration.

FDA Approval 52

FDA Approval Life Science Drugs In-Vivo 52

BioSpace

JUNE 16, 2022

The FDA approved Rhythm Pharmaceutical’s Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome.

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FDA Approval In-Vitro Marketing Development 40

Pharmaceutical Technology

NOVEMBER 22, 2022

The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.

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The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on 22 April 2021.

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FDA Approval DNA Protein In-Vitro 40

XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). About 80 percent of acute cases are asymptomatic.

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RNA In-Vitro Genotype Marketing 97

XTalks

DECEMBER 19, 2023

billion Company: Pfizer Disease it is FDA-approved to treat: Comirnaty is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. billion in sales in 2022.

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Sales FDA Approval Drugs Vaccine 64

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. The hard problem: innovation for high prevalence, chronic diseases of ageing.

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Gene Therapy In-Vitro Gene Medicine 98

Camargo

MARCH 25, 2021

Its purpose is to stimulate the development of new drugs for rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products beyond the incentives offered by the ODD program. The FDA must deem the application eligible for priority review (i.e., The estimated demand in the US for the product.

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Production Drugs In-Vitro Containment 130

XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Join us as we explore the inspiring journey and significant contributions of these top 10 medical device companies.

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FDA Approval Production Sales In-Vitro 98

XTalks

NOVEMBER 7, 2022

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

MARCH 15, 2022

The TruSight Oncology in vitro diagnostic (IVD) test is being launched first in Europe and according to Illumina’s cancer head Kevin Keegan can match patients with suitable therapies “according to clinical guidelines or clinical trials, based on their tumour profile.”

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Gene Genomics Genome Gene Sequencing 52

The Pharma Data

JANUARY 27, 2021

The collaboration with Bruker announced today will assess the suitability of the test as a professional-use in-vitro diagnostic (IVD) product for SARS-CoV-2 infection to run on Bruker’s MALDI-TOF instruments for sale in the UK and Europe. I look forward to updating the market when we have definitive clinical performance data.”.

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Reagent In-Vitro FDA Approval Development 52

XTalks

AUGUST 8, 2024

The US Food and Drug Administration (FDA) has approved Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel) for adults with unresectable or metastatic synovial sarcoma who have specific HLA types and have undergone prior chemotherapy. It is also the first new treatment for adults with synovial sarcoma in over a decade.

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Engineer Clinical Trials Clinical Trials FDA Approval 52

The Pharma Data

DECEMBER 20, 2020

The FDA approval of Klisyri is a significant milestone for Athenex,” said Johnson Lau, chairman and chief executive officer of Athenex. Approval demonstrates our ability to execute upon the entirety of the drug development and registration process. The FDA completed a class 2 response in July 2020.

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In-Vitro FDA Approval Drugs Manufacturing 52

The Pharma Data

FEBRUARY 12, 2022

On January 21, 2022, the FDA approved a supplemental new medicine operation (sNDA) for Veklury to expand the suggestion to the treatment ofnon-hospitalized grown-up and adolescent cases who are at high threat of progression to severe COVID-19, including hospitalization or death. About the CARAVAN Study (GS-US-540-5823).

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In-Vitro RNA FDA Approval Drugs 52

The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Food and Drug Administration (FDA)-approved for this use and there is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials In-Vitro 52

XTalks

MARCH 6, 2024

Brain Awareness Week 2024 , taking place March 11 to 17 this year, is a global campaign that aims to demystify the complexities of the human brain and promote the significance of neuroscientific research. This relates to neurological conditions like dementia and Alzheimer’s disease, which account for up to 70 percent of dementia cases.

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FDA Approval In-Vitro Research Marketing 69

FDA Law Blog

JULY 8, 2021

Javitt — For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). At various points and in various ways, FDA has sought – mostly unsuccessfully – to regulate LDTs (see here ).

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Regulation In-Vitro Production Genetics 52

XTalks

DECEMBER 11, 2023

Their groundbreaking Tablo Hemodialysis System, cleared by the US Food and Drug Administration (FDA) for use from hospital to home, signifies a monumental leap in technology, revolutionizing the dialysis experience for patients while streamlining operational aspects for providers. In 2021, Axonics achieved an impressive revenue of $180.3

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Production Sales In-Vitro Development 110

Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., It is important to note that these studies are required by U.S.

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Research Vaccine Vaccination Drugs 112

XTalks

APRIL 18, 2024

There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies.

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Clinical Trials Clinical Trials In-Vitro Protein 52

The Pharma Data

OCTOBER 29, 2021

4 Cariprazine is retailed as VRAYLAR in the United States and is FDA-approved to treat depressive, acute manic and mixed occurrences associated with bipolar I complaint, as well as schizophrenia in grown-ups. Cases treated with cariprazine at1.5 Cases treated with cariprazine at3.0 mg/ day or3.0 mg/ day cure. mg/ day or3.0

In-Vitro 40

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