The US Food and Drink Administration (FDA) has approved Calliditas Therapeutics' Tarpeyo (budesonide) delayed-release capsules to reduce the loss of kidney function in adults with IgAN.
The US Food and Drug Administration (FDA) has approved a topical foam developed by Arcutis Biotherapeutics and branded as Zoryve for the skin condition seborrheic dermatitis in people aged nine years and up.
The oral treatment belzutifan, developed by MSD (known as Merck in the US) and branded as Welireg, has received the green light from the US Food and Drug Administration (FDA) for the treatment of an advanced form of renal cell carcinoma (RCC).
Adults and children in the US with congenital thrombotic thrombocytopenic purpura (cTTP) can now access Adzynma for prophylactic and on-demand treatment.
Symbiosis Pharmaceutical Services can now test small molecule, biological and advanced therapeutical medicinal products (ATMP) following a £1 million investment.
EDETEK and Pfizer are in collaboration to speed access to clinical data, promote interoperability and enable data visualization to drive faster decision-making capabilities in clinical operations.
A partnership between clinical research technology company uMotif and cognitive science company, Cogstate Limited, will see the companies continue existing work that includes a major phase 2 clinical trial of a psychedelic therapeutic.
It was announced today (October 31), that the US Food and Drug Administration (FDA) has granted permission to proceed with clinical investigations of small molecule treatment, roginolisib.
Feedback has been submitted to the US Food and Drug Administration (FDA) with guidelines intended for sponsors of clinical trials related to psychedelic compounds.
Novartis announced today (October 2) that it is excited about positive top-line results from its study into iptacopan, a drug to treat IgA nephropathy (IgAN).
The US Food and Drug Administration (FDA) has given orphan drug designation (ODD) to Redx’s Zelasudil for the potential treatment of idiopathic pulmonary fibrosis (IPF).
A kidney disease drug with a ‘durable and clinically meaningful impact on kidney function’ has been granted priority review by the US Food and Drug Administration (FDA).
LighthouseAI, a company that specializes in compliance solutions for the pharmaceutical supply chain, has announced a $2.25 million seed round, led by Healthy Ventures with participation from Bertelsmann Next.
Patients suffering from catheter-related bloodstream infections could be treated with Citius Pharmaceuticals antibiotic lock solution after it achieved 92 milestone events in its phase 3 trial.
2San, a supplier of self-diagnostic tests, has partnered with Proov to distribute their proprietary at-home fertility tests in select Hy-Vee stores across eight states in the Midwest.
This year’s CPHI South East Asia is expecting a surge in international partnering with organizers expecting a record attendance of 8,000 visitors including a significant number from overseas – doubling last year’s figures.
Positive phase 3 results from a trial studying fruquintinib, in patients with previously treated colorectal cancer (CRC) were announced by Hutchmed and Takeda on Friday (June 16).
The US Food and Drug Administration (FDA) has announced this month (June) it is requesting feedback on draft recommendations and how they should be applied to increasingly diverse trial types and data sources.
Vedanta Biosciences has obtained fast track designation from the US Food and Drug Administration (FDA) for its live biotherapeutic VE303, a preventative treatment for recurrent Clostridioides difficile infection (CDI).
Results from a multinational trial of trifluridine/tipracil, known as Lonsurf, with or without bevacizumab in refractory metastatic colorectal cancer (mCRC) have resulted in statistically significantly and clinically meaningful improvements.
A single-agent treatment for patients with relapsed or refractory myelodysplastic neoplasms has shown promising results, including overall survival, in a study.
An agreement has been reached to promote Cingulate Inc’s ‘first true entire active day medication’ designed to treat attention deficit hyperactivity disorder (ADHD).
A powerful tool that could capture abdominal aortic aneurysms (AAA) and refer those at risk is the first to be given clearance by the US Food and Drink Administration (FDA).
Children in Europe living with HIV are on course to receive a once-daily treatment after EU marketing authorisation (EMA) was given to ViiV Healthcare’s Triumeq PD.
A Florida doctor has been sent to prison after submitting a false affidavit claiming she had screened children in a clinical study looking at the effectiveness of drugs given to children with asthma when she had not.
A federal judge in the Southern District of Florida has sentenced two Florida women to prison for their part in a conspiracy to falsify clinical trial data.
The physIQ monitoring platform will be used to evaluate an inhaled treatment, developed by InCarda, that is intended to treat atrial fibrillation patients.
With updates to the Guideline for Good Clinical Practice Advancements on the horizon, an industry expert offers some perspective on what might be ahead.
The Foundation for Sarcoidosis Research hosted more than 50 agency leaders in a session that addressed patient concerns in research, care, and diagnosis.