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. Orgovyx (relugolix) FDA Approval History.

FDA Approval 52

FDA Approval FDA Science Therapies 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

Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

Production 134

Production Clinical Trials Trials Therapies 134

Broad Institute

OCTOBER 11, 2023

By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA. As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014.

Research 137

Research Immune Response Clinical Trials Therapies 137

The Pharma Data

MAY 17, 2023

ABBOTT RECEIVES FDA APPROVAL FOR ITS SPINAL CORD STIMULATION SYSTEMS TO TREAT CHRONIC BACK PAIN IN PEOPLE WHO HAVE LIMITED SURGICAL OPTIONS Abbott (NYSE: ABT) announced today that the U.S. years with pain, is the largest randomized controlled trial for SCS in people with chronic back pain when surgery is not an option.

FDA Approval 40

FDA Approval FDA Therapies Doctors 40

The Pharma Data

JANUARY 15, 2021

15, 2021 — An inhaled medication might make every day physical activity a bit easier for patients with serious scarring of the lungs, a new clinical trial finds. Right now, no medication is approved specifically for pulmonary hypertension caused by ILD, said Dr. Steven Nathan, senior researcher on the new trial.

Disease 52

Disease Doctors Trials FDA Approval 52

KIF1A

APRIL 25, 2024

However, we needed to wait for Susannah to finish her trial before we could submit to the FDA for Sloane’s ASO use. February 2024 – n-Lorem submitted an IND (investigational new drug) to the FDA for Sloane. March 2024 – The FDA approved the IND, and the administering doctor (Dr.

Therapies 52

Therapies FDA Approval FDA Treatment 52

The Pharma Data

MARCH 30, 2021

About the Phase 3 ADVANCE Study The pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the preventive treatment of migraine in those with 4 to 14 migraine days per month.

Treatment 52

Treatment FDA Doctors FDA Approval 52

PLOS: DNA Science

OCTOBER 17, 2024

FDA approved a treatment for type 3 of the ultra-rare genetic disease September 20. The new drug is taken with miglustat , which FDA approved for use in NPD3 in 2009. The original approved was in 2003 to treat a type of Gaucher disease. Thirty-nine of the participants also took miglustat during the trial.

Disease 52

Disease FDA Approval Drugs Treatment 52

The Pharma Data

APRIL 6, 2022

Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022. . Robinson, M.D., ” About Presbyopia.

Trials 52

Trials FDA FDA Approval Clinical Trials 52

The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Do not start any new medicines until you have told your doctor that you have received BOTOX ® Cosmetic in the past.

Doctors 52

Doctors FDA Approval Treatment Production 52

The Pharma Data

SEPTEMBER 8, 2021

–Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluate the use of BOTOX® (onabotulinumtoxinA) for chronic migraine –These data further demonstrate AbbVie’s commitment to harnessing and sharing innovative science and working to advance treatment options for people with migraine across the migraine spectrum.

Doctors 52

Doctors Treatment Trials Clinical Trials 52

Drug Target Review

AUGUST 3, 2023

Clinical trials are now underway for various genetic subtypes of both rare and common diseases, on the understanding that medications utilising genetic biomarkers have a significantly higher chance of success. There are clinical trials underway for genetic subtypes of rare and common diseases.

DNA 52

DNA Clinical Trials Trials Disease 52

Codon

NOVEMBER 3, 2024

Still, while these developments provide cause for hope, each drug or vaccine faces a variety of challenges, ranging from financial incentives for clinical trials to the difficulty of discovering new antimicrobials that pass safety and efficacy tests. A phase 3 clinical trial for M72/AS01E, funded by the Gates Foundation, began this year.

Vaccine 86

Vaccine Trials Therapies Treatment 86

The Pharma Data

SEPTEMBER 10, 2021

Levodopa/Carbidopa Intestinal Gel (LCIG) Reduces Fluctuations and Shortens Time to On Without Troublesome Dyskinesia in Advanced Parkinson’s Disease: Post-Hoc Analyses of 54-week LCIG-Monotherapy Trial. Adult Patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6%

Doctors 52

Doctors Clinical Trials Disease Therapies 52

The Pharma Data

MARCH 7, 2022

With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market, and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. Call your doctor for medical advice about side effects. Tumor lysis syndrome (TLS).

Treatment 52

Treatment FDA Approval Pharmaceuticals Production 52

The Pharma Data

DECEMBER 11, 2020

Operation Warp Speed, the White House-led initiative to develop and distribute vaccines, has already said it plans to begin shipping the vaccine to all 50 states within 24 hours of an FDA approval. Instead, a modified version of the vaccine will be tested in a smaller trial set to begin in February, the newspaper said.

Vaccine 52

Vaccine FDA Hospitals Doctors 52

The Pharma Data

JANUARY 20, 2021

“We are working closely with the FDA in hopes of offering Esbriet to people with UILD, a rare and debilitating disease.”. The sNDA is based on results from a pivotal, 24-week Phase II trial, which was the first randomized controlled study specifically designed and conducted solely in people with UILD. About the Pivotal Study.

FDA 40

FDA Disease Doctors Treatment 40

The Pharma Data

AUGUST 9, 2021

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. ” The U.S.

Vaccine 52

Vaccine Treatment FDA FDA Approval 52

The Pharma Data

APRIL 1, 2021

” Recently, the European Commission (EC) approved RINVOQ (15 mg) for use in adults with active psoriatic arthritis. . ” The safety profile of upadacitinib was generally similar to results reported previously in rheumatoid arthritis trials. The long-term extension of the trial is ongoing. About RINVOQ (upadacitinib).

Doctors 52

Doctors Treatment Therapies Disease 52

The Pharma Data

JANUARY 26, 2021

“Notably, the 70 percent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial. It remains under review by the FDA. INDIANAPOLIS, Jan.

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA ® was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

FDA Approval 40

FDA Approval Treatment Therapies FDA 40

The Pharma Data

OCTOBER 23, 2020

Remdesivir gets full FDA approval to treat COVID. Remdesivir’s full approval Thursday by the FDA comes after the agency granted it emergency use authorization last spring. National Institutes of Health, the FDA announced in a statement. Doctors say this reflects India’s younger and leaner population.

Hospitals 52

Hospitals Virus FDA Government 52

The Pharma Data

JUNE 18, 2021

The GLOW study is a randomized, open label Phase 3 trial comparing progression-free survival in patients treated with either I+V or C+O as assessed by an Independent Review Committee. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. Venetoclax is approved in more than 80 countries, including the U.S.

Treatment 52

Treatment Therapies FDA FDA Approval 52

The Pharma Data

OCTOBER 24, 2020

Remdesivir gets full FDA approval to treat COVID-19. Remdesivir’s full approval Thursday by the U.S. National Institutes of Health, the FDA announced in a statement. Doctors say this reflects India’s younger and leaner population. 22 news release.

Hospitals 52

Hospitals Virus FDA Government 52

The Pharma Data

JUNE 18, 2021

Additionally, there are other ongoing company-sponsored and investigator-initiated trials exploring the potential of ibrutinib and venetoclax in combination for CLL treatment, including the Phase 3 GLOW study. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. Call your doctor for medical advice about side effects.

Treatment 40

Treatment FDA Therapies FDA Approval 40

The Pharma Data

OCTOBER 25, 2020

FDA approval. In a sample of charts from 56 patients with SCD, voxelotor increased hemoglobin by more than 1 g/dL on average and decreased hemolysis markers to a degree consistent with the randomized controlled HOPE trial results. Patients are advised to call their doctor for medical advice about side effects. .

Treatment 40

Treatment Disease FDA FDA Approval 40

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 FDA Clinical Trials Treatment 52

The Pharma Data

DECEMBER 12, 2020

In some disappointing vaccine news, Sanofi and GlaxoSmithKline said Friday that their experimental coronavirus vaccine did not work well in older adults, delaying the start of their late-stage clinical trial that had been set to begin in the United States in December, the Times reported.

Vaccine 52

Vaccine FDA Approval FDA Nurses 52

The Pharma Data

JUNE 26, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs. Do not stop taking XARELTO ® without talking to the doctor who prescribes it for you.

Doctors 52

Doctors Treatment Hospitals Clinical Trials 52

The Pharma Data

MAY 13, 2021

WITHOUT doctors, physical therapists or chiropractors. Our Unique Solution Has Been Featured All Over The Media, From Hallmark, The Doctors, Atlanta Live & Arizona Midday…. I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! And then got my Doctor of Pharmacy (Pharm.

Pharmacy 52

Pharmacy Doctors Production Therapies 52

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial. KENILWORTH, N.J.–(BUSINESS Verquvo (vericiguat) 2.5

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

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. Finally, the committee came up with a list of recommendations for the structure of additional trials, listed in the meeting minutes.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. The submission of an application for the pediatric indication of thromboprophylaxis after Fontan procedure is planned in the EU as well. EINSTEIN-Jr. About the EINSTEIN-Jr.

FDA 52

FDA Clinical Trials Treatment Therapies 52

PLOS: DNA Science

JANUARY 11, 2024

The physician assistant mentions he’ll need two extra vials of blood for new cancer screening tests, one just FDA-approved, the other available as part of a clinical trial. A mammogram found my breast cancer early; a doctor who noticed a bump in my throat found thyroid cancer.

DNA 98

DNA FDA Approval Clinical Trials Treatment 98

The Pharma Data

MAY 4, 2021

down 21%, driven by a negative impact from the COVID-19 pandemic resulting in a decline in patient visits to doctors for preventative health purposes, as well as the loss of patent protection in the U.S. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

The Pharma Data

JANUARY 4, 2021

Food and Drug Administration (FDA) , in combination with Tecentriq ® (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations. chief medical officer and head of Global Product Development. “We

Therapies 52

Therapies FDA Immune Response Treatment 52