Monday, March 30, 2020

Monday, March 30, 2020

Latest News

Medical screw with superalloy receives FDA approval

The Europa Pedicle Screw System received FDA 510(k) approval at the end of March.

FDA Market Clearance for new Cranial Electrotherapy Stimulator

A new treatment for anxiety, depression and insomnia may be on the way now that Innovative Neurological Devices received FDA market clearance for its Cervella Cranial Electrotherapy Stimulator (CES).

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves treatment for patients with a type of inflammatory arthritis

The U.S. Food and Drug Administration today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new oral treatment for multiple sclerosis

The U.S. Food and Drug Administration today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease

U.S. FOOD AND DRUG ADMINISTRATION: FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards

The U.S. Food and Drug Administration today posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C.

U.S. FOOD AND DRUG ADMINISTRATION: FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids

The U.S. Food and Drug Administration announced the issuance of two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications, including tramadol.

U.S. FOOD AND DRUG ADMINISTRATION: USDA, EPA, and FDA Recognize April as Winning on Reducing Food Waste Month

The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) kick off Winning on Reducing Food Waste Month by calling for greater collaboration with public, private, and nonprofit partners as well as state and local officials to educate and engage consumers and stakeholders throughout the supply chain on the need to reduce food loss and waste.

DAIICHI SANKYO: Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib, an investigational FLT3 inhibitor, currently under Priority Review for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

CSA MEDICAL INC.: Receives FDA Breakthrough Device Designation and IDE Approval for its RejuvenAir® System for COPD Patients with Chronic Bronchitis

CSA Medical today announced that its RejuvenAir® System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA) and received unconditional IDE (Investigational Device Exemption) approval to initiate a pivotal clinical study to treat patients with moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB). The RejuvenAir® System utilizes a Metered Cryospray of liquid nitrogen at -196◦C to targeted areas within the lungs.

11 drugs recalled during March, FDA reports

Eleven drugs were recalled in March to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.

U.S. FOOD AND DRUG ADMINISTRATION: FDA and CBP bolster collaboration to protect public health and safety

The U.S. Food and Drug Administration and the U.S. Customs and Border Protection (CBP) leaders signed an agreement today to maximize inspection and detection capabilities in order to prevent illegal and harmful products entering the U.S. through the nation’s International Mail Facilities (IMFs) and Ports of Entry that pose a threat to public health

U.S. FOOD AND DRUG ADMINISTRATION: FDA expands approved use of metastatic breast cancer treatment to include male patients

The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

LSK BIOPHARMA: LSK BioPharma and Jiangsu Hengrui Medicine Announce FDA Clearance to Initiate a Phase 3 Clinical Trial in Advanced Hepatocellular Carcinoma (HCC)

LSK BioPharma (or "LSKB"), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or "Hengrui"), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, announced that the Companies have received FDA clearance to initiate a clinical trial in the United States in first-line patients with advanced hepatocellular carcinoma (HCC), evaluating the safety and efficacy of LSKB's rivoceranib, a selective VEGFR-2 inhibitor commonly known as apatinib, in combination with Hengrui's camrelizumab (SHR-1210), a humanized anti-PD-1 monoclonal antibody currently under NDA review in China for classic Hodgkin's Lymphoma (cHL).

U.S. FOOD AND DRUG ADMINISTRATION: FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

The U.S. Food and Drug Administration issued a warning letter to Inova Genomics Laboratory (Inova) of Falls Church, Virginia, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness.

INNOBLATIVE DESIGNS, INC.: Innoblative's SIRA™ RFA Electrosurgical Device Receives FDA Clearance

Innoblative Designs, Inc. (Innoblative), a private medical device company committed to developing next generation, advanced-energy surgical solutions, announced it received U.S. Food and Drug Administration (FDA) clearance for its SIRA™ RFA Electrosurgical Device, a novel radiofrequency ablation (RFA) applicator that supplies energy for use in electrosurgery, specifically for intraoperative coagulation and ablation of soft tissue.

NANOVIRICIDES, INC.: Provides Update on Pre-IND Meeting with the US FDA, GLP Safety/Toxicology Studies to Begin Soon, Multiple Kg Scale Drug Production Accomplished at Its Own Facility

NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to treat difficult and life-threatening viral diseases, reports that US FDA has responded to its request for a pre-IND meeting.

FDA grants De Novo review to LOADPRO spine sensor

The U.S Food and Drug Administration granted a De Novo review for a device intended to be used in the spine.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

The U.S. Food and Drug Administration today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).

Tentative FDA approval granted for generic Sernivo

The Food and Drug Administration (FDA) has given tentative approval for the generic version of Sernivo Spray 0.05% from Perrigo Company.

FDA Health News