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
If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. The post Magazine: CRISPR gene therapies cut through in 2023 appeared first on Pharmaceutical Technology.
In 2001, a Time Magazine cover story touted Novartis’ targeted leukemia treatment Gleevec (imatinib) as a new kind of “am | Shorla Oncology has scored an FDA approval for its strawberry-flavored drink version of Novartis' cancer drug Gleevec. Dubbed Imkeldi, it becomes the first oral liquid form of imatinib.
The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults with bullous pemphigoid (BP), a condition that predominantly affects the elderly. In February 2025, the FDA accepted Dupixent’s supplemental biologics licence application (sBLA) for priority review.
The company said it will now share the results with the FDA as part of the Galleri premarket approval application (PMA), along with preliminary data from a screening study in 140,000 volunteers aged 50 to 77, conducted with the UK NHS, that is being run in 150 locations across England, with final results expected next year.
MSD has received US Food and Drug Administration (FDA) approval for Enflonsia (clesrovimab-cfor) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. Can pharma tariffs “Make America Manufacture Again”? Credit: MargJohnsonVA/Shutterstock.
YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). Can pharma tariffs “Make America Manufacture Again”? Credit: aipicte/Shutterstock. Don’t let policy changes catch you off guard.
“For the first time,… US patients facing recurrent LG-IR-NMIBC each year have access to an FDA-approved medicine,” Barrett said. UroGen’s president and chief executive officer, Liz Barrett, said the approval “represents a significant step forward for [the] company and for the treatment of recurrent LG-IR-NMIBC”.
Tisento Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational oral medicine, zagociguat, for mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), a rare mitochondrial disease. Can pharma tariffs “Make America Manufacture Again”?
Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation. In 2003 the Human Genome Project provided the first atlas.
Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals.
Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals.
KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market. Samsung Biologics (KRX: 207940.KS) We are extremely glad to.
Food and Drug Administration (FDA) has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the. The post FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Endometrial Carcinoma appeared first on Pharma Mirror Magazine.
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it had entered into a commercial supply agreement with Blueprint Medicines following FDA approval of GAVRETO™ (pralsetinib).
The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and huge growth in contract services due to the recent surge in IND applications – with 75 annual FDA approvals expected by 2025.
The company also announced the US FDA has granted Fast Track designation for efgartigimod in primary Sjogren’s disease. Data from the ALKIVIA study showed significant improvements in muscle strength and physical function in myositis patients treated with efgartigimod. This field is required.
.’s (“Labnovation”) COVID-19 Antigen Rapid (“ART”) Test Kit, which is imported by Clearbridge and registered for use in the Philippines, has been recently approved by the Food and Drug Administration (“FDA”) of the Philippines for self-testing.
We are going to make this country the hub of biotechnology innovation,” RFK Jr said during a US Food and Drug Administration (FDA) roundtable on cell and gene therapy on 5 June. Can pharma tariffs “Make America Manufacture Again”? wants to ensure the ensuing the US does not lag behind other countries in drug development. “We
The post metaMe Health partners with Indegene to launch Regulora(R), an FDA-cleared Prescription Digital Therapeutic for adults with Irritable Bowel Syndrome appeared first on Pharma Mirror Magazine. According to a survey of nearly 2,000 patients, IBS sufferers.
Spearheaded by a former US FDA Investigator and seasoned pharmaceutical executive, FD-AID is uniquely positioned to bring a wealth of expertise and insight to India’s rapidly growing pharmaceutical industry.
However, this medication had recently raised controversies when the Food and Drug Administration (FDA) announced a product recall of this drug from the market due to the presence of. The post 6 Reasons Why Ranitidine Is Harmful and How It Caused Cancer to Many appeared first on Pharma Mirror Magazine.
The US Food and Drug Administration (FDA) has expanded the indications of an imaging agent developed by GE HealthCare, which will likely put it at the forefront of the Alzheimer’s diagnostics arena. Last month, the FDA approved the Lumipulse G test , the first blood test to help diagnose the disease.
In the United States, for example, the Food and Drug Administration (FDA) plays a central role, while the European Medicines Agency (EMA) oversees regulations in the European Union. Good Manufacturing Practices The post Navigating Regulatory Compliance in the Pharmaceutical Industry appeared first on Pharma Mirror Magazine.
Designed to guarantee the optimal functioning of any freeze dryer, irrespective of the brand, Usifroid platform integrates a global service of improvement technical support to freeze drying processes around the world while ensuring its adaptation to the latest industrial requirements standards and GMP and FDA recommendations in the field of.
In the United States, the Food and Drug Administration (FDA) set out some very broad guidelines concerning nutrients that should be included in baby formula. The post Choosing a Baby Formula appeared first on Pharma Mirror Magazine.
A shortage of a commercially available drug is one of the criteria that allows compounded production, according to US Food and Drug Administration (FDA) legislation. By GlobalData Learn more about Strategic Intelligence The FDA declared the Wegovy shortage over in April, however, signalling a boost to Novo Nordisk’s market prospects.
.– Borody’s track record includes effective treatment for Peptic Ulcers & Crohn’s Disease, recolonisation of bowel microbiome, and 3 FDA approved drugs on the market.– The post Topelia Australia launches US$25M Series A call for COVID-19 ATT Ziverdox appeared first on Pharma Mirror Magazine.
Capable of delivering any FDA approved. The post Maculus Therapeutix welcomes Privity FZ LLE and Prepares Capital Raise for Novel Drug Delivery Platform appeared first on Pharma Mirror Magazine. Maculus achieved the breakthrough using a patented novel tunable biodegradable proprietary product, MacuBloc.
Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g., l)(1) (e.g.,
The first tranche will be received by Revolution, following US Food and Drug Administration (FDA) approval of daraxonrasib to treat metastatic PDAC by January 2028. Can pharma tariffs “Make America Manufacture Again”?
The US Food and Drug Administration (FDA) has awarded ABS-1230 both orphan drug and rare paediatric designations. Can pharma tariffs “Make America Manufacture Again”?
Exxua, developed by Fabre-Kramer Pharmaceuticals, is a selective serotonin 5HT1a receptor agonist that has gained approval from the US Food and Drug Administration (FDA) for treating MDD in adults. Can pharma tariffs “Make America Manufacture Again”?
Vivien Santillan, ISPE Philippines Affiliate Vice President, concurred adding “I have personally witnessed his dedication in his field as he has also assisted the Philippines and unselfishly shared his knowledge and expertise with the industry and the FDA.
It’s been a busy month for Gilead, with the US Food and Drug Administration (FDA) approving the company’s injectable pre-exposure prophylaxis (PrEP) for HIV product Yeztugo (lenacapavir). Can pharma tariffs “Make America Manufacture Again”?
Historical performance data, like that provided in FDA Drug Trials Snapshots, has shown that using traditional recruitment practices by themselves does not enhance the diversity of clinical trial populations. The post A collaborative approach to greater diversity in clinical trials appeared first on.
The post Medical Writing — An Outsourcing Competency appeared first on Pharma Mirror Magazine. As a result, well-designed manuscripts can be published faster, and results can reach the public faster and more cost-effectively.
Last November, it claimed FDA approval for MI Cancer Seek, a now-launched diagnostic test that can identify patients who can benefit from targeted treatments for solid tumours.
We organize all of the trending information in your field so you don't have to. Join 5,000+ 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