RhoVac's Prostate Cancer Drug Candidate, RV001, is granted Fast Track Designation by the FDA
RhoVac, a clinical stage company announced that the American FDA has granted Fast Track Designation to the company's drug candidate, RV001. Fast
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VIATRIS INC.: Announces FDA Tentative Approval of a Pediatric Formulation of Dolutegravir (DTG) Under PEPFAR
Tentative approval will help enhance access to WHO-recommended pediatric medicine and reduce the cost of HIV treatment for children in low- and middle-income countries
FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
The U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu.
REGENERON: REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization
First treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2
EIGER BIOPHARMACEUTICALS: Announces FDA Approval of Zokinvy™ (lonafarnib): The First Treatment for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies
Zokinvy increases survival by 2.5 years in children and young adults with Progeria
ELI LILLY AND COMPANY: Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19
ACTT-2 data serve as basis for EUA, the second COVID-19 authorization for a Lilly treatment
FDA: Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs
The U.S. Food and Drug Administration approved Stelfonta (tigilanol tiglate injection) to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors (MCTs).
AMYLYX PHARMACEUTICALS: Announces FDA Granted Orphan Drug Designation for AMX0035 for the Treatment of Wolfram Syndrome
Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035 for the treatment of Wolfram syndrome.
AGILENT: Receives Expanded FDA Approval for PD-L1 IHC 22C3 pharmDx in Triple-Negative Breast Cancer
Announcement marks the seventh cancer type for which PD-L1 IHC 22C3 pharmDx has gained approval in the US
LUPIN: Announces FDA Filing Acceptance of Supplemental New Drug Application for Solosec® (secnidazole) for the Treatment of Trichomoniasis
Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has accepted their supplemental New Drug Application (sNDA) for Solosec® (secnidazole) for the treatment of trichomoniasis in adults and adolescents.
EXEGI PHARMA: Announces FDA Orphan Drug Designation for EXE-346 Live Biotherapeutic
ExeGi Pharma LLC, a company focused on developing live biotherapeutic ("LBP") drugs and probiotics, announced today that its biologic drug candidate, EXE-346, has received an orphan drug designation from the U.S. Food and Drug Administration (FDA) for the prevention of disease relapse in pouchitis.
HERON THERAPEUTICS: Resubmits New Drug Application to FDA for HTX-011 for the Treatment of Postoperative Pain
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain.
SEBELA PHARMACEUTICALS: Receives FDA Approval for SUTAB® Tablets for Colonoscopy Preparation
SUTAB® Tablets with Active Sulfate Ingredients Give Gastroenterologists a New, Safe, and Effective Alternative to Liquid Bowel Preparations
ANGIOCRINE BIOSCIENCE: Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL® Cell Therapy)
Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL® Cell Therapy) to Treat Organ Vascular Niche Injuries for the Prevention of Severe Toxicities in Lymphoma Patients undergoing Curative High-Dose Therapy with Autologous Stem Cell Transplantation
NATIONAL ALLIANCE FOR HISPANIC HEALTH: Statement on FDA Issuing New Guidance on Enhancing Diversity of Clinical Trials
FDA strongly endorsed diversity in clinical trials as central to good science and drug safety." said Dr. Jane L. Delgado, PhD, MS, President and CEO of the National Alliance for Hispanic Health, the nation's leading Hispanic health advocacy group. "Now responsibility for making it happen is with clinical trial sponsors and FDA review boards. The guidance must be a part of any future COVID-19 vaccine or drug approval."
ELI LILLY AND COMPANY: Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Eli Lilly and Company's (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg.
SEDOR PHARMACEUTICALS: Receives FDA Approval for SESQUIENT™ (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients
Room-temperature stable formulation aids timely point-of-care administration
IMPEL NEUROPHARMA: Announces FDA Submission Of New Drug Application For INP104 For The Acute Treatment Of Migraine
The INP104 New Drug Application is Supported by Results from the Phase 3 STOP 301 Study
CANNABICS: Concludes a Pre-Clinical Study on Human Biopsies in Preparation for FDA pre-IND Meeting Request on Colorectal Cancer Drug Candidate RCC-33
Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and medicines, announced today that it has completed a pre-clinical study using its proprietary and novel RCC-33 formulation on human biopsies, obtained under a Helsinki Committee approved protocol.
AMO PHARMA LIMITED: FDA Grants Rare Pediatric Disease Designation to AMO Pharma for AMO-02 for Treatment of Congenital Myotonic Dystrophy
AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on rare, childhood onset neurogenetic disorders with limited or no treatment options, announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease (RPD) designation to AMO-Pharma for AMO-02, the company's investigational therapy in development for the treatment of congenital myotonic dystrophy.