The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. Related Articles: Danyelza (naxitamab-gqgk) FDA Approval History. NEW YORK, Nov.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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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. The speed and rigor with which Veklury has been developed and approved in the U.S.

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. References [1] 2023 Novel Small Molecule FDA Drug Approvals. 2] Iversen et al.,

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Chemical Biology and Drug Design

NOVEMBER 20, 2023

We employed a combined strategy involving molecular docking-based virtual screening, molecular dynamics (MD) simulation, and MM/GBSA free energy calculation on existing FDA-approved drugs. Sorafenib and glimepiride simultaneously downregulated c-Maf protein expression to induce G1 phase arrest and apoptosis in myeloma cells.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. Related Articles: Imcivree (setmelanotide) FDA Approval History.

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The Pharma Data

AUGUST 14, 2020

In other news, Genentech’s Evrysdi (risdiplam) has secured FDA approval for the treatment of spinal muscular atrophy and Bristol Myers Squibb has announced positive data from two Phase 3 clinical trials of its drug Opdivo. Genentech’s Evrysdi becomes first FDA-approved oral treatment for spinal muscular atrophy.

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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The Pharma Data

AUGUST 28, 2020

China’s ‘insect’ vaccine for COVID-19 approved for human testing. FDA approves Phase 1 trial for HIV gene therapy. The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. FDA approves Novartis’ MS drug Kesimpta for treating relapsed forms of the disease.

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Chemical Biology and Drug Design

OCTOBER 24, 2023

However, potent FDA-approved inhibitors were identified against druggable PmrB-pocket, bypassing the mutation loci. Furthermore, PmrB having high druggability confidence (>0.99), was explored as a potential target for 1396 virtually screened FDA-approved drug candidates. pneumoniae.

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The Pharma Data

SEPTEMBER 11, 2020

Genetech scores sixth FDA approval in lung cancer with Gavreto. Genentech’s once-daily oral therapy Gavreto (pralsetinib) has secured FDA backing in the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), it has emerged.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s first FDA approval. PALO ALTO, Calif.,

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS –(BUSINESS WIRE)– Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. Fill out the form to read the full article.

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Drug Target Review

APRIL 12, 2024

This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. He is co-inventor of SEED Biosciences’ core technology called DISPENCELL and co-authored several patents and scientific articles that made the cover of SLAS Technology in 2020.

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KIF1A

JUNE 3, 2023

In this week’s article, researchers in Japan investigated the genetics of hereditary spastic paraplegia in a retrospective study : this means they went back and analyzed existing data, in this case the genetics and clinical profiles of 37 children diagnosed with HSP.

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The Pharma Data

FEBRUARY 1, 2021

Related Articles: Plegridy (peginterferon beta-1a) FDA Approval History. Poster presented at: Americas Committee for Treatment and Research in Multiple Sclerosis – 2020 Forum; 2020 Feb 27-29; West Palm Beach, Florida, USA. 4 Combined post-marketing data based on prescriptions for Plegridy as of September 30, 2020.

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Drug Target Review

APRIL 12, 2024

This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. He is co-inventor of SEED Biosciences’ core technology called DISPENCELL and co-authored several patents and scientific articles that made the cover of SLAS Technology in 2020.

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KIF1A

JULY 1, 2023

Taking a drug that shelved during development or didn’t receive FDA approval, and assessing its application for another disease, is called drug repositioning. Read the Article The post #ScienceSaturday: July 1, 2023 appeared first on KIF1A.

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DrugBank

FEBRUARY 1, 2024

The article highlights the myriad ways in which we have focused on making DrugBank not just a knowledgebase, but a vital partner in your healthcare research. newsworthy, explore the full Nucleic Acids Research article. Our latest update, DrugBank 6.0, was recently profiled in the January 5, 2024 issue of Nucleic Acids Research.

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New Drug Approvals

SEPTEMBER 10, 2024

Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,

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Agency IQ

MAY 17, 2024

Following FDA approval, these products are granted seven years of marketing exclusivity, preventing FDA from approving the “same drug for the same disease or condition” if the applicant does not have the right to reference the product (i.e., DORIS MATSUI (D-Calif.) and GUS BILIRAKIS (R-Fla.), TAMMY BALDWIN (D-Wisc.).

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BMG Labtech

JANUARY 18, 2023

And if you need to take an FDA-approved drug, there’s around a one in three chance that it’s a drug that targets a GPCR. In the first part of this blog article, we look at what GPCRs are, some of their responsibilities in the cell, and the overall approaches used to study these signaling molecules.

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Drug Target Review

MAY 15, 2024

3 The value required is more than just a greater number of FDA approvals, it is also about completing milestones with limited capital – ie, biotech survival. The latter group (ie, most of us) are waiting for wet lab validation, market demonstration (FDA approvals), and a few other things (which we often cannot define).

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Food and Drug Administration (FDA).

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FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

Beyond his regulatory acumen, Dr. Won is an accomplished author, boasting a portfolio of more than 40 peer-reviewed journal articles, spanning various aspects of hearing devices (see his Google Scholar page ). The comprehensive agenda for the symposium can be accessed in its entirety here.

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New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] 1] It is taken by mouth. [1] Hz, 1 H), 4.62−4.75

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Alta Sciences

APRIL 17, 2024

In this blog article, we review some of these areas of investigation where Altasciences has robust expertise and solution offerings. According to a 2022 article published in Molecular Psychiatry, treatment resistance affects 20 to 60% of patients with psychiatric disorders. Asia, and Europe.

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Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

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Agency IQ

JULY 26, 2024

Prior to CARES Act reforms, FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as they adhered to pre-set terms under the monograph. Read AgencyIQ’s explainer on the CARES Act here.

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The Pharma Data

NOVEMBER 30, 2020

The company plans to seek FDA approval of the test, and the agency has given the test a designation that can speed its review, said C2N Diagnostics Chief Executive Joel Braunstein, M.D., AP News Article. . “It’s not quite clear how accurate or generalizable the results are,” she told the AP. the AP reported.

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New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

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The Pharma Data

JANUARY 27, 2021

Our objective is to work with Bruker and our clinical partners to deliver an effective and high throughput assay protocol, that can be applied in the clinical setting, with the required sensitivity and specificity and CE/FDA approvals to provide a useful additional diagnostic tool in the fight against the coronavirus.

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New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. 1 It was approved by the FDA on August 19, 2024. Food and Drug Administration (FDA).

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National Institute on Drug Abuse: Nora's Blog

APRIL 10, 2023

mfleming Mon, 04/10/2023 - 14:43 Nora's Blog April 13, 2023 Image Getty Images/ AleksandarGeorgiev This article originally appeared in the Milken Institute’s Power of Ideas series. Is It Too Soon To Start Talking about a Cure for Addiction? Our country remains in the grips of an opioid crisis claiming more than 100,000 lives every year.

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New Drug Approvals

SEPTEMBER 20, 2023

Jump up to: a b “Aphexda approval letter” (PDF). Motixafortide 4F-benzoyl-TN-14003 BKT-140 BKT140 BL-8040 Protein Chemical FormulaC 97 H 144 FN 33 O 19 S 2 Protein Average Weight2159.6 8 September 2023. Archived from the original (PDF) on 14 September 2023.

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