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Internal stress could break the FDA's streak of consistently high novel agent approval counts, despite beginning 2026 with almost as many goal dates as the past three years even though biologics center submissions plunged.
While drug manufacturers are unlikely to “pull out of the EU entirely,” geopolitical shifts driven by US tariff threats will mark a “categoric shift” as big pharma tries to “placate the Trump administration,” an analyst says.
Human-centric design, a risk-based approach and lifecycle management are among the ten guiding principles for artificial intelligence (AI) that pharma should follow when using AI in the drug lifecycle, the FDA and EMA say in a joint document.
New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.
India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.
Saol Therapeutics cannot conduct a new clinical trial of SL1009 in ultra-rare mitochondrial disorder, but aims to answer the FDA's complete response letter with new looks at available data.
FDA reviewers cited several limitations of the videos, including a lengthy recall period, use of the term “today” in questions, and a lack of standardization in interview conduct.
The Pink Sheet’s Drug Review Profile looks at the clinical development and US FDA review timeline for Stealth's elamipretide for Barth syndrome.
Stealth BioTherapeutics' diligent response to the FDA’s accelerated approval suggestion, its justification for proposed confirmatory trial milestones, and the rarity of Barth syndrome gave the agency confidence to grant approval before the postmarketing study began.
Using artificial intelligence in drug discovery and development could have huge benefits for companies, but a key challenge will be addressing how data is used to train AI tools and managing intellectual property issues, says Clifford Chance’s Stephen Reese.
Pink Sheet interviews with ex-FDA leaders and agency experts offer guidance for drug developers navigating an agency playing by a different and ever-shifting rulebook.
India’s moves on digital data protection don’t pose a hurdle to patient recruitment, but on the wish list of global innovators is permission for first-in-human (FIH) trials and removal of certain commercialization requirements, says Parexel’s India head
Alternatives to animal testing can replace lengthy, resource-intensive studies for drug developers, helping to lower costs for companies, but a lack of regulatory global alignment can be a barrier to reducing animal testing, an expert says.
