Food and Drug Administration (FDA) News This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

FDA Adds Fasenra Indication for Severe Asthma in Children
TUESDAY, April 16, 2024 -- The U.S. Food and Drug Administration has approved an additional indication for Fasenra (benralizumab) as an add-on maintenance treatment for patients aged 6 to 11 years with severe asthma and an eosinophilic... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 16, 2024 Category: Pharmaceuticals Source Type: news

FDA Roundup: April 16, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 16, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Zimbabwe: Zimbabwe Issues Recall On Benylin Paediatric Syrup
[263Chat] The Medicines Control Authority (MCAZ) has issued a public health alert following a communication received from the National Agency for Food and Drug Administration (NAFDAC) of Nigeria regarding the recall of Benylin Paediatric 100ml Syrup. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - April 16, 2024 Category: African Health Tags: Health and Medicine Southern Africa Zimbabwe Source Type: news

Advance in immune cell screening uncovers receptors that target prostate cancer
This study validated the ability for nanovials to find T cells, and their receptors, that react to viruses.A second experiment with a different patient applied the technology to a much more challenging problem: rare prostate cancer targets the scientists had identified in previous studies. Importantly, those molecular targets acted to both capture the T cells and cause them to secrete certain molecules that kill target cells. In other experiments, the nanovials also had molecules allowing each to capture more than one type of immune-activating secretion.CNSI at UCLAA closer look at UCLA-developed nanovials, which are hydro...
Source: UCLA Newsroom: Health Sciences - April 15, 2024 Category: Universities & Medical Training Source Type: news

Dank Dividends: 3 Cannabis REITs Offering High Yields
Here are just a few hot cannabis REITs that could see higher highs Cannabis real estate investment trusts ( ) could see higher highs on a few key catalysts. For one, hedge fund manager Dougie Kass of Seabreeze Capital recently said the Food and Drug Administration (FDA) would soon reschedule…#dougiekass #seabreezecapital #fda #pewresearch #iipr #saferbankingact #ffo #afcgamma #eps #tdcowen (Source: Reuters: Health)
Source: Reuters: Health - April 15, 2024 Category: Consumer Health News Source Type: news

FDA pauses Watertown biotech ’s schizophrenia trial
The U.S. Food and Drug Administration placed a clinical hold on a Watertown biotech ’s schizophrenia drug trial after new pre-clinical data showed convulsions in rabbits. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - April 15, 2024 Category: Pharmaceuticals Authors: Hannah Green Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study
Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphomaData from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meetingBasel, 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates fo...
Source: Roche Investor Update - April 15, 2024 Category: Pharmaceuticals Source Type: news

[Ad hoc announcement pursuant to Art. 53 LR] Roche ’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study
Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphomaData from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meetingBasel, 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates fo...
Source: Roche Media News - April 15, 2024 Category: Pharmaceuticals Source Type: news

FDA Roundup: April 12, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

16 Bit gets FDA nod for AI x-ray software
Canadian AI software developer 16 Bit has received de novo approval from the U.S. Food and Drug Administration (FDA) for Rho, an AI tool for evaluating low bone mineral density (BMD). Rho uses patented AI technology to automatically scan standard x-rays (frontal projections of the chest, thoracic spine, lumbar spine, pelvis, knee, and hand/wrist) for markers of low BMD, an indicator of osteoporosis, 16 Bit said. The software could improve screening for osteoporosis, as screening rates using dual energy x-ray absorptiometry scans are low in the U.S., the company noted. (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - April 12, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Artificial Intelligence Source Type: news

Former FDA Director to Speak at Executive War College on FDA ’s Coming Regulation of Laboratory Developed Tests
Tim Stenzel, MD, PhD, will discuss what clinical laboratories need to know about the draft LDT rule, FDA memo on assay reclassification, and ISO-13485 harmonization Many clinical laboratories anxiously await a final rule from the US Food and Drug Administration (FDA) that is expected to establish federal policies under which the agency will regulate laboratory […] The post Former FDA Director to Speak at Executive War College on FDA’s Coming Regulation of Laboratory Developed Tests appeared first on Dark Daily. (Source: Dark Daily)
Source: Dark Daily - April 12, 2024 Category: Laboratory Medicine Authors: Jillia Schlingman Tags: Laboratory Management and Operations Laboratory News Laboratory Resources Laboratory Testing News From Dark Daily Pathology and Clinical Laboratory Conferences Abbott Laboratories anatomic pathology Asuragen clinical pathology dark int Source Type: news

Fasenra Approved for Treatment of Children Aged 6 to 11 with Severe Asthma
WILMINGTON, Del.--(BUSINESS WIRE) April 11, 2024 --AstraZeneca’s Fasenra® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 11, 2024 Category: Drugs & Pharmacology Source Type: news

Biotech reporter Garde departing STAT News
National biotech reporter Damian Garde is leaving STAT News for a new opportunity. Garde was part of a team that won a 2022 Polk Award for reporting about covert lobbying of the U.S. Food and Drug Administration. He co-writes The Readout newsletter and co-hosts “The Readout LOUD” podcast. Prior to…#damiangarde #statnews #readout #readoutloud #stat #fiercebiotech #patchcom #albuquerquejournal (Source: Reuters: Health)
Source: Reuters: Health - April 11, 2024 Category: Consumer Health News Source Type: news

USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plant
The US Food and Drug Administration (USFDA) has issued a warning letter to Kilitch Healthcare India for manufacturing lapses at its plant in Maharashtra. The letter highlights various violations of current good manufacturing practice (CGMP) regulations, including packing drugs in insanitary conditions and failing to establish proper procedures to prevent contamination. The USFDA observed that the facility was poorly cleaned and maintained, posing risks of contamination. Kilitch Healthcare has committed to suspending production of all drugs for the US market. The company must address the violations and provide a plan for co...
Source: The Economic Times Healthcare and Biotech News - April 11, 2024 Category: Pharmaceuticals Source Type: news

Simpson Interventions OCT-guided system gets FDA nod
The U.S. Food and Drug Administration (FDA) has granted Simpson Interventions' Acolyte Image Guided Crossing and Re-Entry Catheter system Breakthrough Device Designation. The system facilitates the placement and positioning of guidewires and catheters within the coronary vasculature for treating patients with coronary chronic total occlusions who continue to experience symptoms following medical treatment. It provides real-time optical coherence tomography visualization, supporting effective guidewire placement within the target vessel's true lumen and subsequent revascularization. Simpson Interventions said it is workin...
Source: AuntMinnie.com Headlines - April 11, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Subspecialties Cardiovascular Radiology Source Type: news