CYRAMZA, in combination with erlotinib, now approved for the treatment of people with untreated metastatic non-small cell lung cancer (NSCLC) with certain activating EGFR mutations, based on the positive global Phase 3 RELAY study
ZILXI™ Now Approved for Inflammatory Lesions of Rosacea in Adults
The U.S. Food and Drug Administration granted approval to Oriahnn (an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
Approval Marks Significant Advance Towards a More Definitive Assessment of Alzheimer’s Based on Brain Imaging
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced that the U.S. Food and Drug Administration (FDA) has approved VESIcare LS™ (solifenacin succinate) oral suspension for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older.
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
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
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
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.
Accurate Diagnostic Labs, in collaboration with RUCDR Infinite Biologics, will continue to significantly increase active infection testing access to the country, as the FDA has cleared the groundbreaking saliva collection methodology to be used at home by patients, at the request of their health care provider.
The U.S. Food and Drug Administration approved Tabrecta (capmatinib) for the treatment of adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body.