This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
The US Food and DrugAdministration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. The guidelines address the safety, effectiveness or quality of these medicines.
SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. Where to start?
The US Food and DrugAdministration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies.
All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the Food and DrugAdministration (FDA) set up rigorous standards for vaccine developers to meet.
Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and DrugAdministration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.
The authors highlighted the variations in methods advised in guidelines from the US Food and DrugAdministration (FDA) and European Medicines Agency (EMA) were a contributing factor. As such, this “could impact the need for rigorous quality control measures, such as pyrogen testing”.
The US Food and DrugAdministration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’ssafety, tolerability and efficacy.
Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and DrugAdministration (FDA). Tzield clinical trials that supported the US Food and DrugAdministration approval.
The US Food and DrugAdministration (FDA) has sent a warning letter to KVK-Techs drug manufacturing facility following an inspection in April 2019. Key violations identified by the FDAFDA investigators reported specific violations including, but not limited to: 1. Whats next for KVK-Tech?
UK-based pharmaceutical giant GSK has announced that the US Food and DrugAdministration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.
The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. We need a 21st-century approach that puts patient safety first.
Draft guidance published by the US Food and DrugAdministration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.
The US Food and DrugAdministration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). Furthermore, the favourable pharmacokinetic, safety and tolerability profile of REL-1017 was in line with data reported in prior Phase I trials.
Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and DrugAdministration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. Safety data for up to two years is included in the analysis.
US Food and DrugAdministration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. What recommendations are included in the draft guidance on psychedelic drugs?
The US Food and DrugAdministration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.
The Office of Pharmaceutical Quality (OPQ) in the US Food and DrugAdministration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products. percent) to be noncompliant.
To date, there are no US Food and DrugAdministration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica.
The US Food and DrugAdministration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. The post First-in-class phosphate absorption inhibitor approved by FDA appeared first on European Pharmaceutical Review.
The US Food and DrugAdministration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for early Alzheimer’s, Eli Lilly and Company revealed. In some cases, this occurred in less than 12 months, which is why fewer patients stayed on the drug for a full year.”
The US Food and DrugAdministration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.
The US Food and DrugAdministration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. Indicated for administration rectally, Rebyota is a single-dose 150ml microbiota suspension. .
The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and DrugAdministration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising.
AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and DrugAdministration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu-treated subjects had a median overall survival (OS) of 23.4
The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 The post Promising schizophrenia drug faces tough competition appeared first on European Pharmaceutical Review.
The US Food and DrugAdministration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.
The US Food and DrugAdministration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.
The US Food and DrugAdministration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. According to the interim efficacy data from a pre-specified patient cohort, a 5.4
The US Food and DrugAdministration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. The trial has confirmed its safety and efficacy for the treatment of pain and fever in the targeted patients.
The US Food and DrugAdministration (FDA) has granted Fast Track designation for Eli Lilly and Company ’s tirzepatide to treat adults with obesity or overweight with weight-associated comorbidities. .
The US Food and DrugAdministration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
Pfizer has submitted a New Drug Application (NDA) to the US Food and DrugAdministration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk.
Biopharmaceutical company Novaliq has received approval from the US Food and DrugAdministration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.
The US Food and DrugAdministration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients.
A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. Johnson & Johnson’s Phase I study is assessing the safety and efficacy of TAR-210 as a delivery method for sustained, local release of erdafitinib into the bladder.
The US Food and DrugAdministration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% With the latest development, Opzelura has became the first treatment for repigmentation in patients with vitiligo to receive FDA approval.
The world’s first AI-generated anti-fibrotic small molecule inhibitor drug has been administered to the first human patients. Phase II clinical trials in the US and China are now underway for INS018_055, Insilico Medicine’s potentially first-in-class oral drug candidate. Patients will be divided into four parallel cohorts.
FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and DrugAdministration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.
SAB Biotherapeutics has received breakthrough therapy designation (BTD) from the US Food and DrugAdministration (FDA) for SAB-176, an investigational immunotherapy to treat influenza. SAB-176 received fast-track designation from FDA in mid-April 2023.
The US Food and DrugAdministration (FDA) has approved gene therapy Lenmeldy (atidarsagene autotemcel) as the first treatment for children with early-onset metachromatic leukodystrophy (MLD). The post FDA approves innovative gene therapy for MLD appeared first on European Pharmaceutical Review.
The US Food and DrugAdministration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). The post FDA approves first Stelara biosimilar, Wezlana appeared first on European Pharmaceutical Review. US sales of Stelara totalled $6.4
The US Food and DrugAdministration (FDA) has approved two landmark cell-based gene therapies for treatment of inherited blood disorder sickle cell disease. Developed by Vertex Pharmaceuticals and CRISPR Therapeutics, Casgevy is the first FDA-approved therapy to use CRISPR/Cas9 genome editing technology.
Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and DrugAdministration (FDA) for the development of artificial intelligence (AI) tools for drugsafety and real-world evidence studies.
The US Food and DrugAdministration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).
We organize all of the trending information in your field so you don't have to. Join 8,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content