BAYER: U.S. Food and Drug Administration Approves Lampit® (nifurtimox) for the Treatment of Chagas Disease in Children
Only Chagas disease treatment approved in U.S. for use in children from birth to less than 18 years of age
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GENENTECH: ADDING MULTIMEDIA FDA Approves Genentech’s Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older
In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA
NEUROX INC.: FDA Grants Inhaled Use IND for RLF-100 (Aviptadil) to Treat Patients With Moderate and Severe COVID-19 Aiming to Prevent Progression to Respiratory Failure
Aviptadil is now shown as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes, while also preventing synthesis of cytokines in the lung
GSK: FDA Approves GSK’s BLENREP (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.
CALIDI BIOTHERAPEUTICS: Announces FDA Approval for COVID-19 Treatment Manufactured by Partner: Personalized Stem Cells
Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, announced that the Investigational New Drug (IND) application submitted by its partner, Personalized Stem Cells, Inc. (PSC), has received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy.
REVIRAL: Announces FDA Fast Track Designation Granted to Sisunatovir For The Treatment of Serious Respiratory Syncytial Virus Infection
ReViral Ltd., a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing antiviral therapeutics that target respiratory syncytial virus (RSV), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sisunatovir for the treatment of patients with serious RSV infection.
LEO PHARMA: Announces U.S. Food and Drug Administration Fast Track Designation for delgocitinib Cream for the Treatment of Adults With Moderate-to-severe Chronic Hand Eczema
The purpose of the Fast Track process is to get important potential new drugs to patients earlier
FDA: Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection
The U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood.
FDA: Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease
The U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older.
FDA: Warns Companies Illegally Selling Hangover Remedies
U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC.
FDA: Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools
The U.S. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.
CHECKMATE PHARMACEUTICALS: Granted FDA Fast Track Designation for CMP-001 Combined with PD-1 Blockade in the Treatment of Certain Types of Metastatic or Unresectable Melanoma
Checkmate Pharmaceuticals, Inc. (Checkmate), a clinical-stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its product candidate, CMP-001
NEOIMMUNETECH: Announces FDA Approval to Proceed with Second Study of NT-I7 (efineptakin alfa) in Adult COVID-19 Patients
NIT’s second trial to evaluate NT-I7’s potential as a COVID-19 therapeutic
ZEBRA MEDICAL VISION: Secures its First FDA Clearance in Oncology, Boosting Early Detection of Breast Cancer in Mammograms
This latest clearance makes Zebra Medical the first AI startup with six FDA clearances across three different modalities under its belt. In initial testing Zebra-Med conducted, a number of cases which were originally missed were alerted by Zebra Medical’s ‘HealthMammo’ algorithm and the patients were recalled and confirmed
PHARMACYTE BIOTECH: Announces Submission of Drug Master File to FDA for Company’s Pancreatic Cancer Therapy
PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced that its partner, Austrianova, has submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA).
ANIXA BIOSCIENCES: Breast Cancer Vaccine Technology Nearing FDA Submission
Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced that its prophylactic breast cancer vaccine is making progress towards clinical trials.
HEMOSHEAR THERAPEUTICS: Receives FDA Fast Track and Rare Pediatric Disease Designations for HST5040 to Treat Methylmalonic Acidemia and Propionic Acidemia
Designations Highlight the Urgent Need for Treatments for These Rare Diseases
VITA THERAPEUTICS: Receives Orphan Drug Designation from FDA for new novel treatment
Vita Therapeutics, Inc. announced that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne's Muscular Dystrophy (DMD).
KITE: U.S. FDA Approves Kite’s Tecartus™, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma
87 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus
FDA: Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection
Authorization is also second to allow testing of pooled samples