CDER proposes to withdraw approval of TAVNEOS
CDER proposes to withdraw approval of TAVNEOS
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CDER proposes to withdraw approval of TAVNEOS
ACP expressed its concerns with the proposed changes to the Office of Management and Budget and urged the agency to revise the proposed rule.
Professor Chris Whitty writes for The i paper on the update to the UK CMOs' physical activity guidelines.
Meet Melanie: Finding Freedom, Confidence, and a New Normal with Type 1 Diabetes mseibold Fri, 07/10/2026 - 15:23 Type 1 Share Your Story By sharing your story, you help us raise awareness of diabetes so we can bend the curve on it once and for all. Will you help us awaken the world? Share Your Story
The gene sequencing company this week named a new chief commercial officer and chief legal officer.
The Japanese medical robotics company, a joint venture between Kawasaki and Sysmex, is preparing for a European launch after expanding in the Asia-Pacific region.
On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvan
Mental health care does not need to become less human to become more effective. The most effective (and responsible) path forward is one built on partnership The post How AI Can Support Better Mental Health Outcomes — With Humans at the Center appeared first on MedCity News .
by Catherine Arundel, Charlie Welch, Luke Strachan, Charlie Peck, Ross Atkinson, Una Adderley, Ian Chetter, Nicky Cullum, Tom Davill, Jane Griffiths, Catherine Hewitt, Charlotte Hirst, Katherine Jones, Maartje Kletter, Julie Mullings, Han Phung, Gareth Roberts, Pedro Saramago, Brigid Smart, Marta Soares, Philip Stather, Nikki Stubbs, Jude Watson, Sabeen Zahra, Jo Dumville Background Strong compression is a recommended first line venous leg ulcer treatment. With limited research comparing the clinical effectiveness of compression wraps (CW) and two-layer compression bandage treatments with…
If you are sitting on a brand strategy right now, the test is not whether your team likes it. The test is whether it can be defended by someone who did not build it, to a board that did not commission it, by a leader who did not hire you. The post Why Most Healthcare Brand Strategies Fail the First Time Leadership Gets Tested appeared first on MedCity News .
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
Extensive planning and team support can help healthcare organizations reduce the risk of falls in hospitals. This will improve patient safety, reduce the burden on operations in inpatient treatment settings, and deliver quality care at all levels of treatment and recovery. The post Why Fall Prevention Must Be a System-Wide Priority in Healthcare Settings appeared first on MedCity News .
The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model.
As football fans across the country get behind England, the MHRA wants to keep any Yellow Cards off the pitch – and instead let people know that Yellow Cards can make an important impact in a very different way by helping make medicines and medical devices safer for everyone.
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
Original new drug approval. solution, intravenous, interstitial. Sponsor: Provepharm Sas
Efficacy supplement (new or revised indication). solution, intravenous. Sponsor: Merck Sharp Dohme
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Merck Sharp Dohme
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Astellas
A call for evidence on standardised packaging for all tobacco products, cigarette papers and herbal smoking products and potentially introducing pack inserts.
Proposals for regulating tobacco, vaping and nicotine product packaging, device appearance and retail displays, to implement the Tobacco and Vapes Act.
KKR, the global investment giant, has launched Allyntra, a new precision-engineered solutions platform for the medtech industry, while also announcing several senior management changes.
PRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata Desogestrel- and etonogestrel-…, Agenda Agenda of the PRAC meeting 6-9 July 2026Draft Reference Number: EMA/PRAC/141965/2026…, PRAC statistics: July 2026 , PRAC statistics: July 2026 English (EN) (174.12 KB - PDF)First published: 10/07/2026 View , Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between…
Objectives This study aims to investigate the knowledge, attitudes and practices (KAP) regarding diabetic nephropathy among patients with diabetes. Design A cross-sectional survey was conducted. Setting The survey was administered in a clinical setting. Participants A total of 410 patients with diabetes completed the questionnaires, with 215 (52.44%) identified as female and 262 (63.9%) not diagnosed with diabetic nephropathy. Interventions Participants provided demographic information and answered questions assessing their KAP through a structured questionnaire. Primary and secondary outcome…