Pink Sheet Perspectives
The UK-US trade deal offers the “the most encouraging signs the industry has seen for many years,” but UK companies had little influence over it and details are still scarce, according to one industry expert.
Accelerated approvals of novel products rebounded in 2025 as drug development adapted to major pathway changes enacted in the FDA Omnibus Reform Act, but pending applications suggest a potentially bigger impact outside oncology in 2026.
The US pharmaceutical market is critical for European pharma companies, but new policies introduced by the Trump administration are creating an increasingly complex and uncertain environment for them.
As Europe races to reclaim its share of commercial clinical trial activity, regulators are testing whether faster approvals and shorter setup timelines will be enough to restore sponsor confidence, attract biotech investment, and secure the region’s place in global drug development.
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.
The FDA starts 2026 with 55 novel agents under review, which are detailed in Pink Sheet's interactive chart.
In 2025, 43 drugs containing new active substances (NASs) were approved in the EU, and 2026 has already seen three NAS approvals with more expected soon. Also, for 1H 2026, the EU regulator has received 84 letters of intent for marketing applications for new drugs, of which 58 contain NASs.
Review times for novel agents approved in 2025 stayed remarkably steady, hugging PDUFA timelines, maintaining high approval volumes, and foreshadowing a new debate over whether ultra‑fast, politically driven reviews will result from the Commissioner's National Priority Voucher program.
Interactive infographic tracking submission to approval for all 58 novel agents approved by US FDA in 2025
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.
Regulatory streamlining including in areas such as test licenses and cell/gene therapy, and policy support/incentives to propel innovation, were among the key themes that played out in India in 2025. More action is anticipated in this year, including in the biosimilars segment.
A new pharma package, fresh laws for biotech and new rules for tackling medicines shortages are among the raft of legal changes that industry must grapple with in the year ahead. Lawyers explain the key changes for pharma companies.
Late 2025 saw a flurry of policy moves in Japan ahead of this April's regular drug reimbursement price revision, with pharma industry groups decrying a related medical fee increase. But other positive changes are set to be implemented.
More complete response letters were issued than approvals for novel neuroscience candidates in 2025. Orphan neurology therapies were hit the hardest.
A look back at South Korea's key biopharma policy and regulatory developments last year and the outlook for 2026, when AI tools look set to play a role in reducing product approval periods.
Products likely to be subject to evidence generation agreements under England’s Innovative Medicines Fund are those that are costly and which serve a low number of patients. Orphan drugs appear most likely to receive interim funding through the IMF.
In 2025, China’s regulatory agencies and biopharma industry reaped the benefits of previous years' efforts to accelerate clinical trial starts and improve commercial insurance coverage for certain innovative medicines.
To give teeth to its enforcement blitz, the FDA could move against companies that have not discontinued or revised ads cited as violative, experts said. In the meantime, the National Advertising Division is serving as an alternative enforcement mechanism.
A wave of FDA warning and untitled letters left drug marketers rethinking risk disclosures, visuals and promotional claims as well as bracing for more enforcement letters in 2026, with a close eye on social media promotion and vaccine advertising.
Pink Sheet's annual listing of novel agents and the review designations they carried