The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. NYSE: PFE) announced today that the U.S. PAXLOVID has been available in the U.S. More than 11.6 million treatment courses of PAXLOVID have been prescribed in the U.S. 11) At this time, the U.S.

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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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The Pharma Data

JANUARY 18, 2021

Biederman, Director of Cardiovascular Imaging and Cardiac MRI at Allegheny General Hospital/Allegheny Health System in Pittsburgh and an author on the groundbreaking 2017 MagnaSafe trial published in NEJM. Impulse Dynamics, based in Marlton, N.J.,

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Drug Discovery World

JUNE 6, 2024

The global Phase III clinical trial is being led by University College London Hospitals NHS Foundation Trust in the UK and will include around 1,100 people. Moderna recently secured FDA approval for the first mRNA vaccine to treat something other than Covid-19 – it’s respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345).

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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. Abstract Carbapenem-resistant Klebsiella pneumoniae (CRKP) infections continue to impose high morbidity threats to hospitalized patients worldwide, limiting therapeutic options to last-resort antibiotics like colistin.

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Drug Discovery World

JUNE 27, 2024

A similar bispecific antibody, emicizumab, manufactured by Genentech, was first granted Food and Drug Administration (FDA) approval for haemophilia A in 2017. This restores the body’s thrombin generation capacity, helping blood to clot.

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Drug Discovery World

DECEMBER 22, 2023

In other news, the FDA approved a promising antibody-drug conjugate for bladder cancer and trial results demonstrated that psilocybin could reduce depression symptoms in cancer patients.

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The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

AUGUST 13, 2020

NS Pharma has claimed a tentative FDA approval for its Viltepso (viltolarsen) injection in the treatment of Duchenne muscular dystrophy (DMD) in patients who are suitable to receive exon 53 skipping therapy. Mutations in the DMD gene can lead to an absence of the muscle cell protein dystrophin.

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Drug Discovery World

DECEMBER 22, 2022

A new drug based on the active ingredient Lutetium-177 PSMA-617 has been approved by the European Commission for the treatment of metastatic prostate cancer carrying the surface molecule PSMA (prostate specific membrane antigen). . It had already received FDA approval for the United States in March of this year.

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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.

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Drug Discovery World

SEPTEMBER 13, 2022

The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2022 by Professor Robin Jones, MD, Head of the Sarcoma Unit at The Royal Marsden Hospital, London. Desmoid tumours are rare, connective tissue tumours that can have aggressive infiltrative growth and a high risk of local recurrence.

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The Pharma Data

FEBRUARY 24, 2022

Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Today, the U.S.

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The Pharma Data

DECEMBER 12, 2020

.” The logistics of a national COVID vaccination campaign are daunting: Every state, along with six major cities, has submitted to the federal government a list of locations — mainly hospitals — where the Pfizer vaccine is to ship initially. Third of Americans live where hospitals are short on ICU beds.

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FDA Law Blog: Biosimilars

AUGUST 7, 2024

ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.” Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.

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Drugs.com

JULY 17, 2023

MONDAY, July 17, 2023 (HealthDay Now) -- Parents now have a new long-acting drug to protect their children against respiratory syncytial virus (RSV), a common germ that hospitalizes as many as 3% of children under the age of 1 in the United States.

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The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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The Pharma Data

MAY 5, 2021

AstraZeneca’s Farxiga (dapagliflozin tablet) has received an expanded indication for lowering the risk of kidney function decline, kidney failure, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease and risk of progression. . .

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Drug Discovery World

AUGUST 24, 2023

“As multiple myeloma progresses and patients cycle through treatments, the disease becomes more difficult to treat and remission periods shorten,” said Maria-Victoria Mateos, Consultant Physician in Haematology, University Hospital of Salamanca. The most common adverse event (AEs) observed in the study was cytokine release syndrome (77%, 1.5%

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Drug Discovery World

OCTOBER 10, 2023

Read more: Another milestone achieved in major depressive disorder trial More accessible treatment The US Food and Drug Administration (FDA) approved Sage Therapeutics’ Zurzuvae (zuranolone) in August, making it the first oral medication indicated to treat postpartum depression (PPD) in adults.

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Drug Discovery World

APRIL 10, 2023

BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif., Outside the U.S.,

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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. Results found that 92.5 Neuroleptic Malignant Syndrome (NMS), a serious condition that can lead to death.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. percent (24/515) for baricitinib plus remdesivir versus 7.1 Wesley Ely, M.D.,

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The Pharma Data

AUGUST 11, 2020

“Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of use of the drug across a range of hospitalized COVID-19 patient populations.”.

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Drug Discovery World

SEPTEMBER 7, 2023

5 The Research to Accelerate Cures and Equity (RACE) for Children Act of 2017 authorised the Food and Drug Administration (FDA) to require paediatric clinical trials for new oncology drugs with relevant molecular targets and has a had a positive impact on the number of drugs approved in paediatric indications.

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The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

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The Pharma Data

NOVEMBER 18, 2020

Still, the country’s public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Doctors say this reflects India’s younger and leaner population. Only the United States has more coronavirus cases. Meanwhile, Brazil passed 5.9

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The Pharma Data

DECEMBER 21, 2020

Now, all that being said, with the Covid-19 pandemic, there is a recommendation from the National Comprehensive Cancer Network for patients with cancer to avoid hospitals and clinics as much as possible. It’s, we believe, one of the reasons we were granted priority review by the FDA.” .

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The Pharma Data

DECEMBER 17, 2020

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

MAY 31, 2022

. “The approval of Evrysdi for pre-symptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” said Richard Finkel, M.D., Jude Children’s Research Hospital.

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The Pharma Data

DECEMBER 3, 2020

The addition of berotralstat through the EAMS will bring a much needed option for HAE patients suffering with this debilitating disease,” said Dr. Sorena Kiani, Consultant Immunologist at Royal London Hospital, London.

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Broad Institute

APRIL 25, 2024

Sabeti and her lab had also responded quickly to Ebola in 2014, working with hospitals and government officials in Sierra Leone to sequence viral genomes from patients and make the data available to local communities. Ozonoff is also an associate professor of pediatrics at Harvard Medical School and a scientist at Boston Children’s Hospital.

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The Pharma Data

JULY 12, 2021

Finerenone 10 mg or 20 mg is indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

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The Pharma Data

JULY 8, 2021

Patients should call their healthcare provider or go to the nearest hospital emergency room right away if they have any of the symptoms listed above. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA.

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The Pharma Data

DECEMBER 16, 2020

Costenbader , Director of the Lupus Program at Brigham and Women’s Hospital in Boston and chair of the Lupus Foundation of America’s Medical-Scientific Advisory Council.

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