FDA: Approves First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease
Approval Marks Significant Advance Towards a More Definitive Assessment of Alzheimer’s Based on Brain Imaging
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BECKMAN COULTER LIFE SCIENCES: FDA Lists Beckman Coulter Life Sciences RNA Extraction Kit For Use In EUA-Authorized COVID-19 Test
Beckman Coulter Life Sciences today announced RNAdvance Viral XP has been added to the list of acceptable extraction methods for use in the Centers for Disease Control's EUA-authorized COVID-19 test referenced in the FDA's FAQ on testing for SARS-CoV-2.
ASTELLAS PHARMA: FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients
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.
REGENERON PHARMACEUTICALS: FDA Approves Dupixent® (dupilumab) as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis
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: Highlights Orphazyme's Receipt of FDA Fast Track Designation for the Development of Arimoclomol in Amyotrophic Lateral Sclerosis (ALS)
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).
FDA: Approves Only Drug in U.S. to Treat Severe Malaria
The U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients.
FDA: Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age
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.
TAKEDA: U.S. FDA Approves Takeda’s ALUNBRIG® (brigatinib) as a First-Line Treatment Option for Patients Diagnosed with Rare and Serious Form of Lung Cancer
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
SUNOVION: Announces U.S. FDA Approval of KYNMOBI™ (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes
First and only sublingual therapy approved for the on-demand treatment of Parkinson’s disease OFF episodes
TRINETX: TriNetX & Harvard Pilgrim Health Care Institute Partner on FDA Sentinel System to Monitor COVID-19 Drug Usage
COVID-19 Clinical Real-World Data Being Utilized to Monitor for Potential Drug Shortages
FDA: Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests
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.
AUTOMATED MARKING INCORPORATED: Solutions For The New FDA Mandated COVID-19 Supply Chain Requirements
Marking, Coding, and Packaging Products are a Key Part of the Critical Supply Chain Overhaul
G MEDICAL INNOVATIONS: VSMS ECG Patch receives US FDA 'Emergency Use Authorisation' for patients being treated for COVID-19
Patch now authorised in the USA for emergency use for patients undergoing treatment for COVID-19
FDA: USDA, FDA Strengthen U.S. Food Supply Chain Protections
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
20/20 GENESYSTEMS: To Provide Newly FDA Authorized COVID-19 Antibody Blood Test
Lab Testing, in Combination with AI-Building Data Collection, Expected to Improve Predictive Power of Antibodies in Pandemic Response
GENENTECH: FDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer
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
KIC WASHINGTON, D.C.: 1-Drop Becomes 6th South Korean COVID-19 Test Kit Maker That Won Emergency Use Authorization (EUA) from U.S. Food & Drug Administration
The KIC Washington Center will continuously support the domestic biotech company's entry into the U.S. market.
BRISTOL-MYERS SQUIBB: U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Pomalyst® (pomalidomide) for AIDS-Related and HIV-Negative Kaposi Sarcoma
Pomalyst is the only oral and first new treatment option for Kaposi sarcoma in more than 20 years
BLUEPRINT MEDICINES: Receives Complete Response Letter from FDA for Avapritinib New Drug Application for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor
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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FDA: Issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients
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