Trump FDA Drug Approvals: How US Regulatory Upheaval Is Reshaping the Global Pharmaceutical Industry The United States Food and Drug Administration has long been regarded as the gold standard of drug regulation. When a medicine receives FDA approval, it carries a...
Product characterisation remains the critical test of submission strength The US Food and Drug Administration (FDA) convened a roundtable on the Premarket Tobacco Product Application (PMTA) process, bringing together discussions on product characterisation,...
Being first to market in a new therapeutic class is often seen as a winning formula in biopharma. In reality, many of the biggest commercial successes come second, or even later. The difference is not luck. It is timing, differentiation and scale. Understanding late...
The evolving PMTA landscape for nicotine pouches The recent FDA authorisation of on! PLUS nicotine pouches is a significant moment in helping meet tobacco harm reduction (THR) goals. They are the first products to pass a new, faster FDA programme, signifying a...
In regulated drug development, documentation shapes how a program is understood long before regulators ever see it. Protocols, investigator brochures, integrated summaries, and submission-ready modules establish the scientific and strategic narrative of a development...
FDA Overhauls Pharmacokinetic Study Requirements in New Biosimilar Draft Guidance The US Food and Drug Administration (FDA) has overhauled biosimilar pharmacokinetic study requirements in new draft guidance issued on 9 March 2026, aimed at further reducing the time...
FDA Overhauls Pharmacokinetic Study Requirements in New Biosimilar Draft Guidance The US Food and Drug Administration (FDA) has overhauled biosimilar pharmacokinetic study requirements in new draft guidance issued on 9 March 2026, aimed at further reducing the time...
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...