The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

Drug Target Review

JUNE 5, 2023

With a commitment to advancing novel medicines and leveraging strategic partnerships, he provides valuable insights into their cutting-edge research and development efforts. It also supports the argument for developing ZW171 for the treatment of other MLSN-expressing solid tumours.

Treatment 100

Treatment Pharmacokinetics Drugs Cell Biology 100

The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sesquient.

FDA Approval 52

FDA Approval FDA Long-Term Care Facilities Treatment 52

The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

FDA Approval 52

FDA Approval Treatment FDA Research Laboratories 52

Broad Institute

MAY 16, 2024

Gene therapy could potentially treat a range of severe genetic brain disorders, which currently have no cures and few treatment options. Mechanism first For years, researchers developed AAVs for specific applications by preparing massive AAV libraries and testing them in animals to identify top candidates.

Therapies 137

Therapies FDA Approval Engineering Disease 137

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.

FDA Approval 52

FDA Approval Treatment FDA Hospitals 52

National Institute on Drug Abuse: Nora's Blog

FEBRUARY 1, 2024

On May 14, 1974, an act of Congress established the National Institute on Drug Abuse (NIDA), and since then NIDA has led the world in funding and conducting research on drug use and addiction. There was little in the way of effective prevention, and the only drug addiction treatment available was methadone.

Science 127

Science FDA Approval Treatment Research 127

The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S.

FDA Approval 52

FDA Approval FDA Treatment Small Molecule 52

The Pharma Data

OCTOBER 8, 2021

Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S. director of the FDA’s Center for Biologics Evaluation and Research. Today, the U.S. Dosing is patient?customized,

FDA Approval 52

FDA Approval FDA Treatment Disease 52

The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. The approval of Oxlumo is a further testament to the impact RNAi therapeutics can have in transforming the treatment of severe, life-threatening diseases like PH1. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Nov.

FDA Approval 52

FDA Approval Treatment FDA RNA 52

Drug Target Review

FEBRUARY 21, 2024

This is a time when several promising treatments – including mRNA vaccines, BiTE therapies and CAR-T cell therapy, are essentially in competition with each other – they all have a common goal of treating the same disease, but they are approaching the objective from different angles.

Therapies 64

Therapies Treatment Vaccine FDA Approval 64

The Pharma Data

OCTOBER 30, 2020

More recently, the FDA announced regulatory approval for the first treatment for Covid-19. Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19.

FDA Approval 52

FDA Approval Vaccine FDA Treatment 52

Broad Institute

FEBRUARY 8, 2024

Researchers uncover genetic factors for severe Lassa fever By Allessandra DiCorato February 8, 2024 Breadcrumb Home Researchers uncover genetic factors for severe Lassa fever New findings from an international collaboration pave the way for studies of highly infectious diseases in Africa such as Ebola.

Research 81

Research Virus Hospitals Disease 81

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] Comenzo, M.D.,

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

FDA Approval 52

FDA Approval FDA Therapies Clinical Trials 52

The Pharma Data

AUGUST 4, 2020

Drug approved to treat major depressive disorder with acute suicidal ideation or behaviour. The approval is based on two phase 3 clinical trials in which Spravato, plus comprehensive standard-of-care, demonstrated a significant and rapid reduction of depressive symptoms within 24 hours. Source link. .

FDA Approval 52

FDA Approval FDA Clinical Trials Trials 52

The Pharma Data

NOVEMBER 12, 2021

Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. Today, the U.S.

FDA Approval 40

FDA Approval Disease FDA Treatment 40

The Pharma Data

AUGUST 7, 2021

Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells. Nexviazyme is expected to be available in the U.S.

FDA Approval 52

FDA Approval Disease FDA Treatment 52

The Pharma Data

DECEMBER 21, 2020

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Professional. MONDAY, Dec. Food and Drug Administration announced Friday.

FDA Approval 52

FDA Approval Therapies FDA Science 52

The Pharma Data

FEBRUARY 24, 2022

Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction.

FDA Approval 52

FDA Approval FDA Treatment Hospitals 52

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Clinical Development 69

Clinical Development Production Clinical Trials Treatment 69

The Pharma Data

JULY 29, 2021

Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.

Biosimilars 52

Biosimilars Production FDA Approval FDA 52

The Pharma Data

JANUARY 17, 2021

plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields. are expected to be approved by the U.S. .

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

Drug Target Review

MARCH 12, 2024

The study’s findings offer new insights into the biochemical language microbes use to influence distant organ systems, which could revolutionise the way researchers approach disease. The diversity and range of functions of these secondary bile acids has been greatly underappreciated by researchers until now. Gut Microbes.

Disease 111

Disease Biochemical Pharmacology FDA Approval Pharmacy 111

The Pharma Data

JUNE 26, 2021

Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceuticals 52

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. Pfizer’s COVID-19 therapy Paxlovid, for example, targets Mpro. .

FDA Approval 52

FDA Approval Molecular Biology FDA Virus 52

The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

FDA Approval 52

FDA Approval Therapies FDA Treatment 52

DrugBank

FEBRUARY 1, 2024

was recently profiled in the January 5, 2024 issue of Nucleic Acids Research. 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. Our latest update, DrugBank 6.0, As part of these latest improvements we’ve added more than 1.2

Research 52

Research Clinical Trials FDA Approval Trials 52

The Pharma Data

APRIL 28, 2023

FDA approves once-weekly Sogroya® for the treatment of children living with growth hormone deficiency Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Sogroya ® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg for the treatment of children aged 2.5

FDA Approval 40

FDA Approval Treatment FDA Disease 40

The Pharma Data

NOVEMBER 23, 2021

director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”.

FDA Approval 52

FDA Approval Treatment FDA DNA 52

The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) has approved belimumab (Benlysta®), the first-ever treatment for adults with lupus nephritis (LN) who are currently receiving standard therapy. The Alliance for Lupus Research ( LRA) President and Chief Executive Officer Kenneth M. GlaxoSmithKline. GSK announced on Thursday that the U.S.

FDA Approval 52

FDA Approval Therapies FDA Treatment 52

The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. in March, 2021.

FDA Approval 52

FDA Approval FDA Pharmaceutical Companies Therapies 52

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. Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S. BOSTON, Nov.

FDA Approval 52

FDA Approval FDA Clinical Trials Therapies 52

The Pharma Data

NOVEMBER 29, 2021

“The FDA’s approval of Cytalux can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected,” said Alex Gorovets, M.D., deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research. “By The FDA, an agency within the U.S.

FDA Approval 52

FDA Approval FDA Drugs Laboratories 52

Drug Target Review

JANUARY 8, 2024

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. Our lead program utilises OSK for the treatment of age-related optic neuropathies.

Science 145

Science Disease FDA Approval Clinical Trials 145

The Pharma Data

JANUARY 22, 2021

Cabenuva (cabotegravir and rilpivirine, injectable formulation) is a complete regimen for treatment of HIV-1 and offers an alternative to the current daily oral antiretroviral regimen. Approval was based on data from the Phase 3 ATLAS and FLAIR studies, two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults.

FDA Approval 52

FDA Approval FDA RNA Clinical Trials 52

PLOS: DNA Science

SEPTEMBER 5, 2024

Researchers from Harvard Medical School describe a new ChatGPT-like model that can guide clinical decision-making to diagnose, treat, and predict survival for several types of cancer. A Brief History of Targeted Cancer Drugs In 1978, FDA approved the first targeted cancer drug, tamoxifen.

Treatment 52

Treatment FDA Approval DNA Small Molecule 52