The Pharma Data

APRIL 26, 2022

director of the FDA’s Center for Drug Evaluation and Research. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”. Learn more about FDA-approved and authorized COVID-19 vaccines. The only approved dosage form is Veklury for injection.

FDA Approval 52

FDA Approval FDA Treatment Vaccine 52

The Pharma Data

AUGUST 24, 2020

The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases. The Phase 1 trial is expected to be conducted at sites in Baltimore, Maryland and Washington, DC.

FDA Approval 52

FDA Approval Therapies FDA Trials 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

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

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 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. Vastly Expanded Clinical Trial Information Our clinical trial data has grown by 89.5%.

Research 52

Research Clinical Trials FDA Approval Trials 52

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

AUGUST 31, 2021

10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response.

FDA Approval 52

FDA Approval Treatment FDA Research Laboratories 52

The Pharma Data

JANUARY 17, 2021

LAPS Triple Agonist (HM15211), a triple agonist, has demonstrated a fatty liver reduction effect of 50% or greater through the recent clinical trials in U.S. Poziotinib , which succeeded in clinical trials for HER2 mutated non-small cell carcinoma (NSCLC) patients last year, is planned to be submitted to the U.S.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 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

Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Oncology research is unique in many ways, including the challenges researchers face.

Trials 52

Trials Clinical Trials FDA Approval Therapies 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. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. BOSTON, Nov. in the first quarter of 2021.

FDA Approval 52

FDA Approval FDA Clinical Trials Therapies 52

The Pharma Data

OCTOBER 30, 2020

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. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

FDA Approval 52

FDA Approval Vaccine FDA Treatment 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. One way we are doing this at Life Biosciences is through partial epigenetic reprogramming.

Science 145

Science Disease FDA Approval Clinical Trials 145

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.

FDA Approval 52

FDA Approval Treatment FDA RNA 52

Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials?

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

Alta Sciences

FEBRUARY 8, 2024

President of Cognitive Research Corporation , examine simple and cognitive domains in clinical and pharmacology studies, including analysis of driving impairment. Tags Clinical Trials Weight 12 In this on-demand webinar, Ingrid Holmes , Vice President of Global Clinical Operations at Altasciences, and Dr. Gary G.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Clinical Development 52

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.

FDA Approval 52

FDA Approval FDA Treatment Therapies 52

The Pharma Data

FEBRUARY 25, 2022

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. and Europe.

FDA Approval 52

FDA Approval FDA Hospitals Clinical Trials 52

The Pharma Data

JANUARY 22, 2021

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. Researchers found no clinically relevant change from baseline in CD4+ cell counts.

FDA Approval 52

FDA Approval FDA RNA Clinical Trials 52

The Pharma Data

DECEMBER 17, 2020

The Alliance for Lupus Research ( LRA) President and Chief Executive Officer Kenneth M. We are particularly proud to see this approval for another indication of belimumab, having funded much of the original research that led to the drug’s development. The FDA approval of Klisyri is a significant milestone for Athenex.

FDA Approval 52

FDA Approval Therapies FDA Treatment 52

The Pharma Data

AUGUST 7, 2021

Nexviazyme has been shown in clinical trials to provide patients with improvements in respiratory function and walking distance. For decades, we’ve made it our responsibility to research how to target the M6P receptor, the key pathway for cellular uptake of enzyme replacement therapy. Patients treated with Nexviazyme had a 2.4-point

FDA Approval 52

FDA Approval Disease FDA Treatment 52

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] Janssen Biotech, Inc.

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

Clinical Trials 52

Clinical Trials Vaccine Trials FDA Approval 52

The Pharma Data

AUGUST 10, 2020

The FDA has approved Olinvyk for the management of moderate to severe pain in adult patients when their pain is severe enough to require an intravenous opioid or if alternative treatments do not work. The drug, from Trevena Inc, was also proven to reduce pain compared to a placebo. Douglas Throckmorton M.D.,

FDA Approval 52

FDA Approval FDA Treatment Trials 52

Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children. Why This Guidance Now?

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

The Pharma Data

JANUARY 22, 2021

This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

FDA Approval 52

FDA Approval FDA Therapies Treatment 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

JUNE 22, 2023

FDA approval Pfizer (NYSE: PFE) announced that the U.S. FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and global lead investigator for TALAPRO-2. The primary endpoint of the trial was rPFS, and overall survival (OS) was a key secondary endpoint.

FDA Approval 40

FDA Approval FDA Treatment Trials 40

The Pharma Data

SEPTEMBER 1, 2021

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

Vial

DECEMBER 5, 2023

Next-generation sequencing (NGS) has revolutionized scientific research and clinical genomics due to high-throughput multiplexing and shed light on genome structure, function, and dynamics. It has become a fundamental tool for researchers to explore the complexities of genetic information and conduct genetic-informed drug development.

Clinical Trials 52

Clinical Trials Trials RNA Bioinformatics 52

Codon

JULY 14, 2024

The creation of synthetic blood is one of the holy grails of biomedical research as it would alleviate such shortages and overcome current barriers to obtaining and storing blood products. However, the subsequent death of another patient thrust Denys into a contentious trial. to the European and Pacific fronts unfeasible.

Production 134

Production Clinical Trials Trials Therapies 134

The Pharma Data

NOVEMBER 18, 2020

The simple nasal swab test, developed by Lucira Health, requires a prescription and people under the age of 14 can’t perform the test on themselves, the FDA said in a statement. The California company said that clinical trials showed 100% of patients were able to perform the Lucira test in about two minutes. percent effective.

FDA Approval 52

FDA Approval FDA Vaccine Virus 52

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . In a separate Research Letter, Simon J.

Research 52

Research FDA Approval Drugs FDA 52

KIF1A

JUNE 3, 2023

Each week, Dr. Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. This question permeates every step of the drug development process, from testing in cells and animal models to clinical trials and regulatory approval.

FDA 98

FDA FDA Approval Trials Disease 98

The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. “I Orgovyx (relugolix) FDA Approval History.

FDA Approval 52

FDA Approval FDA Science Therapies 52