FDA: Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer
The U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.
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Occlutech's Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation
Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH).
FDA: Approves Prosthetic Implant for Above-the-Knee Amputations
The U.S. Food and Drug Administration approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System
SLAYBACK PHARMA: Announces FDA approval of Merzee, generic equivalent of Taytulla® with a Competitive Generic Therapy (CGT) Designation
Slayback Pharma LLC issued the following announcement on Dec. 18.Slayback Pharma LLC announced today that it has received final approval for its Abbreviated New Drug Application (ANDA) for Merzee (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1 mg/20 mcg from the USFDA with a Competitive Generic Therapy Designation.
FDA: Approves First Adjuvant Therapy for Most Common Type of Lung Cancer
The U.S. Food and Drug Administration approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.
FDA: Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts
CANNABICS PHARMACEUTICALS: Initiates In-Vivo Animal Studies for FDA Pre-IND Meeting Package
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 initiated a series of proof of concept (POC), in-vivo, animal model studies to test its drug candidate RCC-33 on mice transplanted with colorectal cancer tumor cell lines.
GT BIOPHARMA: Announces FDA Data - Gtb-3550 Trike™ Reduces Cancer Cells by 61.7% for a High-risk Myelodysplastic Syndromes (HR-MDS) Patient
GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company's proprietary NK cell engager (TriKE™) technology platform is pleased to announce the presentation of additional interim data results for the Company's lead therapeutic candidate, GTB-3550, for the treatment of high-risk myelodysplastic syndromes (HR-MDS).
NEPHRON: Announces FDA Approval of Ketorolac, Signaling New Phase of Growth
Kennedy: Company Excited to Expand Generic Portfolio to Include Non-Respiratory Products
FDA: Warns Companies Illegally Selling CBD Products
The U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA: Authorizes marketing of new device designed to remove dead pancreatic tissue
Agency authorized first device indicated to treat patients with necrotic tissue resulting from complications of acute pancreatitis
REVIVE THERAPEUTICS: Provides Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19 with Plans on Emergency Use Access
Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19.
INTERSCOPE: Announces FDA De Novo Marketing Authorization of the EndoRotor® System for Direct Endoscopic Necrosectomy (DEN)
The First and Only System Designed and Indicated for DEN now Available in the United States and Europe
RAPID MEDICAL: Receives FDA Clearance for the World’s First Steerable Neurovascular Guidewire
DRIVEWIRE™ provides efficient access in difficult neuro and peripheral vascular procedures
FDA: Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs
While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication.
3 SEASONS CAPITAL LLC: Heru, Inc., A 3 Seasons Capital, LLC Portfolio Medical Technology Company, Receives Class 1 Listing With the FDA for Developing a Next-Generation, Artificial Intelligence (AI)-Driven Platform for Vision Diagnostics and Augmentation
Heru, Inc., a 3 Seasons Capital, LLC portfolio medical technology company, has received Class 1 listing with the U.S. Food and Drug Administration (FDA) registration for developing a next-generation, artificial intelligence (AI)-driven platform for vision diagnostics and augmentation. Heru is the first diagnostic application for visual field exams.
ALKERMES: FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831
FDA Sets PDUFA Target Action Date of June 1, 2021
FDA: Takes Additional Actions to Increase the Safety of Laparoscopic Power Morcellators Used in Gynecologic Surgeries
The following quote is attributed to Jeffrey Shuren M.D., J.D., director of FDA's Center for Devices and Radiological Health
ZETROZ: Systems' Wearable Ultrasound Device, SAM, Receives Expanded FDA Re-Approval, Positioning the Company for Market Growth in 2021
Sustained acoustic medicine (SAM) technology, approved by the FDA in 2013 for clinical utilization, sees re-approval for expanded indications in 2020.