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FDA Approves Dovato for Teens Living With HIV
WEDNESDAY, April 10, 2024 -- The U.S. Food and Drug Administration has approved Dovato (dolutegravir/lamivudine) for adolescents living with HIV.The approval is for the treatment of HIV-1 infection in adolescents aged 12 years and older (weighing... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 10, 2024 Category: Pharmaceuticals Source Type: news

Dr Reddy's launches migraine management device in Europe
The launch marks the company's entry into digital therapeutics in Europe, the Hyderabad-based drug major said in a statement. Nerivio is approved by the US Food and Drug Administration (USFDA), and is CE-mark certified in Europe. Dr Reddy's launched Nerivio in India last year. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 10, 2024 Category: Pharmaceuticals Source Type: news

Should I Take Supplements to Sleep? What Experts Think
If you want to understand the importance of sleep, ask someone who spent the previous night tossing and turning. Sleep is a vital function: essential for physical recovery, preparing for the next day, even clearing waste material from the brain. Mounting evidence suggests that getting adequate amounts of sleep each night is even more critical than previously believed, responsible for reducing the risk of serious conditions including dementia, obesity, and stroke. [time-brightcove not-tgx=”true”] Yet so many of us struggle to fall and stay asleep, with more than one-third of U.S. adults failing to get the re...
Source: TIME: Health - April 10, 2024 Category: Consumer Health News Authors: Carly Weeks Tags: Uncategorized Evergreen freelance healthscienceclimate Source Type: news

FDA Approves Abecma for Relapsed, Refractory Multiple Myeloma
TUESDAY, April 9, 2024 -- The U.S. Food and Drug Administration has approved Abecma (idecabtagene vicleucel) as a personalized CAR T-cell therapy for triple-class exposed relapsed or refractory multiple myeloma.The approval is for the treatment of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 9, 2024 Category: Pharmaceuticals Source Type: news

FDA Roundup: April 9, 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 9, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Young Adults May Soon Be Able to Get an RSV Shot
Pfizer Inc.’s RSV shot produced immune reactions in young adults at higher risk of severe illness just as well as in older people, spurring the company’s plans to apply for wider U.S. approval. A single dose of the vaccine, called Abrysvo, produced a strong immune response in adults ages 18 to 59 with conditions such as asthma, diabetes, or chronic lung disease, Pfizer said. Based on the final-stage trial results, the company plans to ask the Food and Drug Administration to extend the shot’s approval to adults 18 and older. [time-brightcove not-tgx=”true”] RSV, or respiratory syncytial ...
Source: TIME: Health - April 9, 2024 Category: Consumer Health News Authors: Madison Muller and Robert Langreth/Bloomberg Tags: Uncategorized healthscienceclimate wire Source Type: news

Trinity ’s Senoptica gets FDA clearance to enter US market
A former Start-up of the Week, Senoptica helps sellers significantly reduce food waste by using tech to identify spoiled goods faster than conventional methods. Irish food-tech start-up Senoptica Technologies has received approval from the US Food and Drug Administration (FDA) to expand its…#senoptica #irish #fda #trinitycollegedublin #brendanrice #stevecomby #drrachelevans #spotify #apple (Source: Reuters: Health)
Source: Reuters: Health - April 9, 2024 Category: Consumer Health News Source Type: news

FDA Approves New Antibiotic for Three Indications
MONDAY, April 8, 2024 -- The U.S. Food and Drug Administration has approved the antibiotic Zevtera (ceftobiprole medocaril sodium for injection) for three different indications, including treatment of adults with Staphylococcus aureus bloodstream... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 8, 2024 Category: Pharmaceuticals Source Type: news

ViiV Healthcare Announces U.S. FDA Approval of Dovato (dolutegravir/lamivudine) for Adolescents Living with HIV
Durham, NC, April 8, 2024– ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 8, 2024 Category: Drugs & Pharmacology Source Type: news

Most Cancer Drugs Granted Accelerated FDA Approval May Not Work
The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients’ lives? In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years. “Five years after the initial accelerated approval, you should have a definitive answer,” said Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the research. “Thousands of people are gettin...
Source: TIME: Health - April 8, 2024 Category: Consumer Health News Authors: Carla K. Johnson/AP Tags: Uncategorized healthscienceclimate wire Source Type: news

Many Cancer Drugs Still Unproven 5 Years After Accelerated Approval
MONDAY, April 8, 2024 -- New research questions the effectiveness of the U.S. Food and Drug Administration ' s accelerated drug approval program after finding that many cancer drugs remain unproven five years later.The study, published Sunday in the... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 8, 2024 Category: General Medicine Source Type: news

Novartis to file for Pluvicto label expansion
Novartis said it will file for a label expansion with the U.S. Food and Drug Administration (FDA) later this year to expand the use of its Pluvicto radiopharmaceutical drug to patients with earlier cases of prostate cancer. Currently, Pluvictro (lutetium-177 [Lu-177] prostate-specific membrane antigen [PSMA]-617) is indicated in adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have previously received other anticancer therapies. The new filing follows additional data from the phase III PSMAfore study that demonstrates favorable overall survival (OS)...
Source: AuntMinnie.com Headlines - April 8, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

Many cancer drugs remain unproven 5 years after accelerated approval, a study finds
Researchers have found that most cancer drugs granted accelerated approval by the U.S. Food and Drug Administration do not deliver on their early promise (Source: ABC News: Health)
Source: ABC News: Health - April 7, 2024 Category: Consumer Health News Tags: Health Source Type: news

Roche and Alnylam present positive results from the Phase II KARDIA-2 study of zilebesiran added to standard of care antihypertensives in patients with inadequately controlled hypertension
The KARDIA-2 study met its primary endpoint demonstrating additive, placebo-adjusted systolic blood pressure reductions of up to 12.1 mmHgat month three. These results were statistically significant and clinically meaningfulZilebesiran demonstrated an encouraging safety and tolerability profile when added to standard of care antihypertensives Basel, 7 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam today released detailed results from the Phase II KARDIA-2 study evaluating the efficacy and safety of a single subcutaneous dose of zilebesiran when added to one of three standard of care (SOC) antihypertensives. T...
Source: Roche Investor Update - April 7, 2024 Category: Pharmaceuticals Source Type: news

U.S. FDA Approves Expanded Use Of J & J's Cancer Cell Therapy U.S. FDA Approves Expanded Use Of J & J's Cancer Cell Therapy
The U.S. Food and Drug Administration on Friday allowed the expanded use of Johnson& Johnson and Legend Biotech ' s Carvykti cell therapy as an earlier treatment for...Reuters Health Information (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - April 6, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology Source Type: news