The second half of 2026 is shaping up to be one of the most consequential periods for FDA drug approval decisions in recent memory. Between mid-July and late August, the US Food and Drug Administration faces a succession of Prescription Drug User Fee Act target action...
The atacicept FDA approval that the nephrology community had been anticipating since January arrived on schedule on 7 July 2026, when the US Food and Drug Administration granted accelerated approval to Vera Therapeutics' atacicept-vymj, to be marketed as Trutakna, for...
If your device connects to a network and runs AI, CE marking under MDR or IVDR is only the first layer for connected medical devices. Two further EU frameworks, the AI Act and the Cyber Resilience Act, can also apply, each with obligations that go beyond what MDR...
Four days from now, the US Food and Drug Administration is due to hand down its atacicept IgA nephropathy decision, ruling on whether the experimental Vera Therapeutics drug becomes the first therapy to target both BAFF and APRIL in adults with the disease. The...
FDA accelerated approval is one of the agency's most powerful and most debated regulatory tools. Designed to speed access to treatments for patients with serious or life-threatening conditions, it has delivered transformative therapies to those with no other options....
Artificial intelligence is no longer experimental in biopharma. It is operational. Across drug discovery and development, AI systems are being used to identify targets, design molecules, optimize mRNA constructs, and simulate biological interactions that were...
In the life sciences sector, long-term success is dependent on more than innovation alone. To secure funding, enter strategic alliances, and achieve leadership in competitive markets, companies must protect their innovations by implementing a strategic intellectual...
My wife underwent major surgery in December 2025. She remained 10 days in a Charlotte, NC, hospital and was then for several weeks supported at home by visiting nurses, a physical therapist and a dietician. We just saw the bill: The hospital and participating doctors...
Rezon Bio announces that its Warsaw-Duchnice facility has received approval from the U.S. Food and Drug Administration (FDA) for the commercial manufacturing of a biosimilar. This milestone represents an important step in the continued development of Rezon Bio's...
Biotech companies today face a delicate balancing act: communicating innovation early enough to build credibility and momentum, while avoiding regulatory and commercial risks that can undermine long-term value. This tension is most evident in how companies talk about...
A German court has granted Halozyme a preliminary injunction that halts the sale of the subcutaneous version of Keytruda in Germany, marking a significant legal win in the companies’ high stakes patent dispute. The decision could complicate Merck’s plans for the...
China’s life sciences sector is poised for a potential regulatory shake-up this week, as stakeholders await clarity on data exclusivity and intellectual property (IP) protection reforms. Earlier this year, the National Medical Products Administration (NMPA) released a...
For decades, the laboratory rat has been the quintessential symbol of biomedical research. Yet, as 2025 draws to a close, a profound shift is reshaping the life sciences landscape. Global regulatory bodies are no longer merely encouraging alternatives to animal...
A Coordinated Effort to Accelerate Approvals The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have launched a new initiative inviting early adopters to trial an accelerated and aligned...
A panel of independent experts convened by the U.S. Food and Drug Administration (FDA) has recommended against approving GSK’s (GSK.L) blood cancer treatment Blenrep, citing concerns over known ocular side effects. The decision prompted a nearly 5% drop in the British...