In the pivotal trial, more than twice as many children achieved clear or almost clear skin and more than four times achieved itch reduction with Dupixent plus topical corticosteroids (TCS) compared to TCS alone
CytRx Corporation (OTCQB: CYTR), a biopharmaceutical research and development company specializing principally in oncology and neurodegenerative diseases, today highlighted that Orphayzme A/S announced they have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the development of arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS).
The U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients.
The U.S. Food and Drug Administration granted approval to VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by mouth, for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older.
Long-Term Results from the Phase 3 ALTA 1L Trial Established ALUNBRIG as a Superior First-Line Treatment Compared to Crizotinib for People with ALK+ Metastatic NSCLC, Including those with Brain Metastases
First and only sublingual therapy approved for the on-demand treatment of Parkinson’s disease OFF episodes
COVID-19 Clinical Real-World Data Being Utilized to Monitor for Potential Drug Shortages
U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
Marking, Coding, and Packaging Products are a Key Part of the Critical Supply Chain Overhaul
Patch now authorised in the USA for emergency use for patients undergoing treatment for COVID-19
The following statement is attributed to Mindy Brashears, Ph.D., USDA Under Secretary for Food Safety, and Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response
Lab Testing, in Combination with AI-Building Data Collection, Expected to Improve Predictive Power of Antibodies in Pandemic Response
Approval based on the Phase III IMpower110 study showing Tecentriq demonstrated a significant overall survival benefit in people with high PD-L1 expression compared with chemotherapy
The KIC Washington Center will continuously support the domestic biotech company's entry into the U.S. market.
Pomalyst is the only oral and first new treatment option for Kaposi sarcoma in more than 20 years
Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application of avapritinib for the treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST).
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Allergan cited for failure to comply with post-approval study requirements; Ideal Implant Inc. cited for failures relating to quality system and medical device reporting regulations
Clinical trials to begin at Miami Cancer Institute and Sanford Health
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infectious diseases, announced today the FDA acceptance of the IND application for an allogeneic iNKT therapy, agenT-797, submitted by its subsidiary, AgenTus Therapeutics.
If approved, AR19 would be the first-ever FDA-approved ADHD stimulant medication designed to resist manipulation for nonmedical use, which may help to deter misuse and abuse by intranasal, intravenous and smoking routes of administration