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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.

RAPID MEDICAL: Receives FDA Clearance for the World’s First Steerable Neurovascular Guidewire

DRIVEWIRE™ provides efficient access in difficult neuro and peripheral vascular procedures

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.

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

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).

NEPHRON: Announces FDA Approval of Ketorolac, Signaling New Phase of Growth

Kennedy: Company Excited to Expand Generic Portfolio to Include Non-Respiratory Products

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).

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.

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

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.

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 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

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 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.

KARYOPHARM: Announces FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy

Oral XPOVIO Now Available as a Treatment Option for Patients with Multiple Myeloma As Early as First Relapse; Significantly Expands Addressable Patient Population

MOLECULIN: Announces FDA Permission to Begin Clinical Study of Annamycin for Sarcoma Lung Metastases

Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) is allowing the company's Investigational New Drug (IND) application to study Annamycin for the treatment of soft tissue sarcoma lung metastases to go into effect.

NSC: National Safety Council Statement on the FDA Advisory Panel Approval of COVID-19 Vaccine and Employers' Subsequent Role

The National Safety Council applauds today's formal recommendation of the Pfizer COVID-19 vaccine and the CDC recommendations that prioritize distributing the vaccine first to healthcare personnel and long-term care facility residents, who need it most urgently.

FDA Reporter