Latest Pharma Insights
Hengrui Bags World-First Approval for Anti-PD-(L)1/TGF-? Agent In China
Hengrui’s relafupu-? (SHR-1701), a bifunctional fusion protein against PD-L1 and TGF-?R2, has been approved in China in combination with chemotherapy as a first-line treatment for HER2-negative, PD-L1-positive advanced gastric/gastroesophageal junction adenocarcinoma.
Scrip - January 8, 2026
Hengrui’s relafupu-? (SHR-1701), a bifunctional fusion protein against PD-L1 and TGF-?R2, has been approved in China in combination with chemotherapy as a first-line treatment for HER2-negative, PD-L1-positive advanced gastric/gastroesophageal junction adenocarcinoma.
Scrip - January 8, 2026
FDA Publishes Draft Guidance On Mandatory Cosmetic Recalls Under MoCRA
FDA’s draft guidance on mandatory cosmetic recalls under MoCRA signals how the agency plans to exercise its new recall authority and urges companies to strengthen compliance, recall readiness and rapid response procedures.
HBW Insight - January 8, 2026
FDA’s draft guidance on mandatory cosmetic recalls under MoCRA signals how the agency plans to exercise its new recall authority and urges companies to strengthen compliance, recall readiness and rapid response procedures.
HBW Insight - January 8, 2026
Hengrui Bags World-First Approval for Anti-PD-(L)1/TGF-? Agent In China
Hengrui’s relafupu-? (SHR-1701), a bifunctional fusion protein against PD-L1 and TGF-?R2, has been approved in China in combination with chemotherapy as a first-line treatment for HER2-negative, PD-L1-positive advanced gastric/gastroesophageal junction adenocarcinoma.
Scrip - January 8, 2026
Hengrui’s relafupu-? (SHR-1701), a bifunctional fusion protein against PD-L1 and TGF-?R2, has been approved in China in combination with chemotherapy as a first-line treatment for HER2-negative, PD-L1-positive advanced gastric/gastroesophageal junction adenocarcinoma.
Scrip - January 8, 2026
US FDA’s Sanitized Clinical Trial Guidance Cuts Gender Language
The FDA’s revised guidance emphasizes biological sex in clinical trials, removing references to gender and health equity considerations.
Medtech Insight - January 7, 2026
The FDA’s revised guidance emphasizes biological sex in clinical trials, removing references to gender and health equity considerations.
Medtech Insight - January 7, 2026
Opportunity For Industry To Shape UK Rules On AI In Health Care
The UK health care products regulatory agency is inviting industry to share its views on how artificial intelligence in health care should be regulated, with input set to shape future rules and guidance.
Medtech Insight - January 7, 2026
The UK health care products regulatory agency is inviting industry to share its views on how artificial intelligence in health care should be regulated, with input set to shape future rules and guidance.
Medtech Insight - January 7, 2026
Gore Takes On Boston Scientific, Abbott With LAAO Specialist Conformal
The one-time implant for patients with nonvalvular atrial fibrillation, Conformal Medical’s CLAAS, reduces stroke risk by preventing blood clot formation in the LAA and cutting the need for long-term oral anticoagulation therapy. Gore’s purchase sees it enter a $7bn market.
Medtech Insight - January 7, 2026
The one-time implant for patients with nonvalvular atrial fibrillation, Conformal Medical’s CLAAS, reduces stroke risk by preventing blood clot formation in the LAA and cutting the need for long-term oral anticoagulation therapy. Gore’s purchase sees it enter a $7bn market.
Medtech Insight - January 7, 2026
Makary Touts ‘AI Revolution’ In Announcing Guidance Docs On Wellness Products, Decision Support Tool
FDA Commissioner Marty Makary announced new guidance documents on wellness products and decision support tools focused on AI technology at CES in Las Vegas. The documents aim to reduce regulatory hurdles and promote innovation while ensuring public safety.
Medtech Insight - January 7, 2026
FDA Commissioner Marty Makary announced new guidance documents on wellness products and decision support tools focused on AI technology at CES in Las Vegas. The documents aim to reduce regulatory hurdles and promote innovation while ensuring public safety.
Medtech Insight - January 7, 2026
FDA Publishes Draft Guidance On Mandatory Cosmetic Recalls Under MoCRA
FDA’s draft guidance on mandatory cosmetic recalls under MoCRA signals how the agency plans to exercise its new recall authority and urges companies to strengthen compliance, recall readiness and rapid response procedures.
HBW Insight - January 8, 2026
FDA’s draft guidance on mandatory cosmetic recalls under MoCRA signals how the agency plans to exercise its new recall authority and urges companies to strengthen compliance, recall readiness and rapid response procedures.
HBW Insight - January 8, 2026
Who’s Hired? Medicines For Europe And IGBA Announce New Leaders
Kicking off 2026 with a raft of changes, Medicines for Europe has appointed Zentiva CEO Steffen Saltofte as president while the IGBA has named CGPA head Jim Keon as chair for 2026. Meanwhile, Accord has named a new UK country head as ANI, Olpha, Outlook and Stada have announced management updates.
Generics Bulletin - January 7, 2026
Kicking off 2026 with a raft of changes, Medicines for Europe has appointed Zentiva CEO Steffen Saltofte as president while the IGBA has named CGPA head Jim Keon as chair for 2026. Meanwhile, Accord has named a new UK country head as ANI, Olpha, Outlook and Stada have announced management updates.
Generics Bulletin - January 7, 2026
Biocon Swallows Up Adalimumab In Full As It Pens Another Semaglutide Deal
Taking full ownership of its Hulio adalimumab biosimilar is among a trio of positive updates from India’s Biocon.
Generics Bulletin - January 7, 2026
Taking full ownership of its Hulio adalimumab biosimilar is among a trio of positive updates from India’s Biocon.
Generics Bulletin - January 7, 2026
Why Is Alvotech Suffering With CRLs?
What exactly is causing Alvotech’s frustrating list of US complete response letters? In a recent call with investors, management shed light on the company’s issues.
Generics Bulletin - January 7, 2026
What exactly is causing Alvotech’s frustrating list of US complete response letters? In a recent call with investors, management shed light on the company’s issues.
Generics Bulletin - January 7, 2026
ConcertAI Brings Platform Thinking To Oncology Data And AI
Cambridge, MA-based company seeks to create two-sided marketplace connecting care delivery insights with biopharma drug development.
In Vivo - January 7, 2026
Cambridge, MA-based company seeks to create two-sided marketplace connecting care delivery insights with biopharma drug development.
In Vivo - January 7, 2026
2026: Redefining Image Quality, Dose And Reconstruction
Atul Gupta, MD and CMO of Royal Philips’ Diagnosis & Treatment business, shares his views about potential developments in imaging and wider medtech in 2026 and the value of AI. He warns that clinicians will not adopt AI they don’t trust, understand or find helpful in real-world conditions.
In Vivo - January 7, 2026
Atul Gupta, MD and CMO of Royal Philips’ Diagnosis & Treatment business, shares his views about potential developments in imaging and wider medtech in 2026 and the value of AI. He warns that clinicians will not adopt AI they don’t trust, understand or find helpful in real-world conditions.
In Vivo - January 7, 2026