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CHMP recommends EU approval of Roche ’s Alecensa as the first adjuvant treatment for resected ALK-positive early-stage lung cancer
If approved, Alecensa will be the first and only ALK inhibitor approved for people with resected ALK-positive early-stage non-small cell lung cancer (NSCLC)The positive recommendation is based on results from the Phase III ALINA study where Alecensa showed an unprecedented 76% reduction in the risk of disease recurrence or death, compared to adjuvant chemotherapy1With about half of people living with early-stage NSCLC experiencing disease recurrence or death following surgery, Alecensa could minimise the risk by treating NSCLC before it has spread2Basel, 26 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today th...
Source: Roche Investor Update - April 26, 2024 Category: Pharmaceuticals Source Type: news

FDA approves Pfizer ’s first gene therapy for rare inherited bleeding disorder
The Food and Drug Administration on Friday approved Pfizer 's treatment for a rare genetic bleeding disorder, making it the company's first-ever gene therapy to win clearance in the U.S. The agency greenlit the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B…#pfizer #beqvez #hemophilia #adamcuker #comprehensiveand #sparktherapeutics #cslbehring #fda #hemgenix #hemophiliaa (Source: Reuters: Health)
Source: Reuters: Health - April 26, 2024 Category: Consumer Health News Source Type: news

Fragments of Bird Flu Virus Found in 1 in 5 Milk Samples
FRIDAY, April 26, 2024 -- Bits of bird flu virus have been discovered in roughly 20% of retail milk samples tested in a national survey, the U.S. Food and Drug Administration said Thursday.The finding suggests that bird flu has spread far more... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 26, 2024 Category: General Medicine Source Type: news

One in Five Milk Samples Nationwide Shows Genetic Traces of Bird Flu
There is no evidence that the milk is unsafe to drink, scientists say. But the survey result strongly hints that the outbreak may be widespread. (Source: NYT Health)
Source: NYT Health - April 25, 2024 Category: Consumer Health News Authors: Emily Anthes and Noah Weiland Tags: Avian Influenza Milk Food Contamination and Poisoning Supply Chain Shopping and Retail Viruses Food and Drug Administration Source Type: news

The U.S. government is taking action to stop ‘cow flu.’ Is it too little, too late?
The U.S. government announced new measures yesterday to slow the spread of the H5N1 influenza virus among cattle, following the revelation that milk sold commercially in 10 states contained fragments of the virus. An order issued by the U.S. Department of Agriculture (USDA) restricts the movement of dairy cattle between states and mandates the reporting of infected cows. The order comes as new genetic evidence suggests cattle infections with the virus, first announced on 25 March, may have started as early as the fall of 2023, and that the virus has likely circulated far beyond the 33 farms in eight states ...
Source: ScienceNOW - April 25, 2024 Category: Science Source Type: news

Provisio's SLT IVUS System gets FDA nod
Provisio Medical's Sonic Lumen Technology (SLT) Intravascular Ultrasound (IVUS) system has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA). SLT provides automatic, real-time, numeric measurements of the flow lumen of blood vessels without the complexities of image interpretation, the company said. It consists of the SLT IVUS P1 System and the SLT IVUS Support Crossing Catheter; the catheter is an over-the-wire intravascular ultrasound catheter with an ultrasound transducer array at the distal end, which also works as a support crossing catheter. Information from the ultrasound signal is used s...
Source: AuntMinnie.com Headlines - April 25, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

FDA Approves New Antibiotic Against UTIs, Pivya (pivmecillinam)
THURSDAY, April 25, 2024 -- As many patients already know, urinary tract infections (UTIs) can recur despite the use of antibiotics. So, it ' s welcome news that the U.S. Food and Drug Administration on Wednesday approved Pivya (pivmecillinam) to... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 25, 2024 Category: General Medicine Source Type: news

FDA approves new medication for uncomplicated urinary tract infections in women
The newly approved oral medication Pivya provides women with another option for treating uncomplicated urinary tract infections, the U.S. Food and Drug Administration announced Wednesday. (Source: Health News - UPI.com)
Source: Health News - UPI.com - April 24, 2024 Category: Consumer Health News Source Type: news

FDA Approves Antibiotic to Treat Urinary Infections
Pivmecillinam, which has been used in Europe for decades, will become available next year to women 18 and older. (Source: NYT Health)
Source: NYT Health - April 24, 2024 Category: Consumer Health News Authors: Andrew Jacobs Tags: Urinary Tract Antibiotics Drugs (Pharmaceuticals) Drug Resistance (Microbial) Infections Bacteria Women and Girls Food and Drug Administration Journal of the American Medical Assn your-feed-healthcare Source Type: news

FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections
April 24, 2024 -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 24, 2024 Category: Drugs & Pharmacology Source Type: news

Bird Flu Outbreak in Cattle May Have Begun Months Earlier Than Thought
A single spillover, from a bird to a cow, led to the infections, a review of genetic data has found. (Source: NYT Health)
Source: NYT Health - April 24, 2024 Category: Consumer Health News Authors: Apoorva Mandavilli Tags: your-feed-science Avian Influenza Disease Rates Cattle Agriculture and Farming Dairy Products Viruses Milk Livestock Diseases Agriculture Department Food and Drug Administration Texas North Carolina Kansas Source Type: news

What to Do About Your Bunions
April Leonard likes to blame her bunions on her husband. In 2017, she accompanied him to a podiatrist appointment for calluses—and went home scheduled for surgery to correct her misaligned toe bone. In retrospect, it was a good thing. “He said, ‘I’d really like you to have this done now, because it won’t get better,’” recalls Leonard, 56, of that unexpected first conversation with the doctor. She had painful bunions on both feet and had started to have trouble handling daily chores on her farm in Missouri. Plus, she didn’t like how they looked. “When I went to the po...
Source: TIME: Health - April 24, 2024 Category: Consumer Health News Authors: Angela Haupt Tags: Uncategorized Evergreen healthscienceclimate Source Type: news

Pasteurized milk includes remnants of H5N1 bird flu, U.S. officials say
The U.S. Food and Drug Administration says that it has found bird flu virus particles in some samples of pasteurized milk. (Source: CBC | Health)
Source: CBC | Health - April 24, 2024 Category: Consumer Health News Tags: News/Health Source Type: news

New Rules Mean 3.6 Million Americans Could Get Wegovy Via Medicare, Costing Billions
WEDNESDAY, April 24, 2024 -- A budget-busting 3.6 million Medicare recipients could now be eligible for coverage of the weight-loss drug Wegovy, a new KFF analysis says.That ’s because the U.S. Food and Drug Administration has approved the use of... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 24, 2024 Category: General Medicine Source Type: news

Traces of bird flu found in pasteurized milk, FDA says, with virus traveling from birds, to cattle, to humans, and chickens
The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows. The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to…#fda #avian #leeannjaykus (Source: Reuters: Health)
Source: Reuters: Health - April 24, 2024 Category: Consumer Health News Source Type: news