Articles

5 Notable Oncology FDA Approvals Granted in May: A B2B Analysis

In May 2026, the FDA granted five major oncology approvals, including a first-in-class combination for non-muscle invasive bladder cancer. This analysis covers the approvals, their competitive impact, and next milestones for pharma teams.

EU Draft Merger Guidelines: Capabilities Treatment Needs Revisiting

The European Commission's draft merger guidelines shift focus to "capabilities," assessing how firms compete and pivot to future markets. This article examines the implications for pharmaceutical mergers and acquisitions.

Weekly Buzz: PHG, KMDA Win FDA Nod; FULC Halts Pociredir; RMD Closes Noctrix Deal; NVS Paces In IgAN

This week, the biotech sector saw a wave of regulatory and business development activity: PHG and KMDA won FDA approvals, FULC halted its pociredir program, RMD closed the Noctrix acquisition, and NVS posted positive data in IgAN. We break down what each event means for pharma teams and investors.

The FDA Amendments Act And Drug Safety: Twenty Years Later

The FDA Amendments Act of 2007 (FDAAA) expanded FDA's authority to monitor drugs post-approval, mandating a population-based surveillance system and new disclosure rules. Twenty years later, progress is clear but the overall safety impact remains hard to quantify, offering key lessons for pharma BD and investors.

May 2026 FDA Oncology Actions: 8 Approvals Reshape the Landscape

In May 2026, the FDA issued 8 oncology and hematology approvals, including durvalumab for high-risk non-muscle invasive bladder cancer. This analysis covers the approvals, their competitive impact, and what to watch next in FDA oncology guidance.

FDA clears U.S. trial of MAIA lung cancer drug for third-line patients

The FDA has cleared MAIA Biotechnology to open U.S. enrollment in the expanded Phase 2 THIO-101 trial of ateganosine for third-line non-small cell lung cancer. This milestone, combined with Fast Track designation, positions MAIA for potential Accelerated Approval and shifts the competitive landscape in late-line NSCLC.

Pharma bets on PD-1/VEGF bispecifics: Is lung cancer the wrong target?

While many drugmakers are focused on lung cancer for PD-1/VEGF bispecifics, emerging evidence shows the liver may offer higher value. This analysis covers the mechanism, key players, and strategic implications for pharma teams.

STAT+: What stripping civil service protections for thousands of federal workers will mean for HHS

President Trump's executive order reclassifying thousands of federal workers under Schedule F removes civil service protections for senior HHS staff, including at FDA, NIH, and CDC. This analysis explains the policy change, its implications for pharmaceutical regulatory processes, and what BD teams should monitor next.

Otsuka Voyxact Data and Pfizer AI Deal Tracker

Drug & pharma latest press release traffic this week clustered on two files: Otsuka’s Voyxact (sibeprenlimab-szsi) kidney-function data in IgA nephropathy, and Pfizer’s license deal with Chai Discovery for generative AI drug design. Here is the BD-relevant readout without the rumor layer.

FDA Priority Review Voucher CNPV: Survival Odds

FDA priority review voucher policy in 2025–2026 is no longer only about transferable tropical-disease or rare-pediatric vouchers. Commissioner Marty Makary’s Commissioner’s National Priority Voucher (CNPV) pilot promises 1–2 month reviews for selected NDAs and BLAs—and that speed is now under public-hearing scrutiny.

OHRP Underfunding and 45 CFR 46 Oversight Risk

The Federal regulations at 45 CFR 46—the Common Rule—still set the baseline for HHS-supported human subjects research. In 2025–2026, deep staffing cuts at the Office for Human Research Protections (OHRP) raised a practical question: who enforces the rulebook when the federal referee is short-handed?

Tip Sheet GLP-1s and Cancer: Key Insights for Pharma BD and Investors

This tip sheet analyzes recent findings on GLP-1s and cancer risk, initiatives to expand cancer care access in Washington State, and the rise of nursing-led oncology research. It provides actionable intelligence for pharma business development, investors, and analysts.

Grail’s Galleri Trial Missed Its Primary Endpoint: What BD Teams and Investors Need to Know

Grail’s NHS-Galleri trial did not show a statistically significant reduction in late-stage cancers. However, a substantial reduction in stage 4 cancers and a shift to stage 3 diagnoses reveal a more nuanced picture for investors and BD teams.

ADC Specialist Sinks on Safety Concerns: What Pharma Teams Need to Know

Shares for ADC Therapeutics fell more than 50% after a Phase 3 trial observed a death rate that at least one analyst believes “may be difficult to accept” for doctors and regulators. The safety signal raises critical questions for the ADC class and competitive landscape in blood cancer.

FDA Voucher Program Under Fire: Pharma and Patient Groups Demand Pause

Drug companies and patient groups are urging the FDA to pause the Commissioner's National Priority Voucher (CNPV) pilot program, which offers dramatically faster drug reviews but has drawn criticism for enabling political influence. The program, which can reduce review times from 10-12 months to 1-2 months, is under investigation by lawmakers concerned about corruption.

Top 10 Pharmaceutical Stocks to Buy for June 2026: A B2B Analysis

This analysis identifies the top 10 pharmaceutical stocks to buy for June 2026, focusing on catalysts, sales growth, and regulatory tailwinds from the EMA. It provides actionable insights for BD teams, investors, and analysts seeking high-upside opportunities.

STAT RFK Second Year Vacancies, Not Vaccines

RFK Jr.’s second year at HHS has been defined by leadership vacancies and policy shifts at the NIH, not vaccine debates. For pharma BD and strategy teams, the key signal is the implementation of Schedule F, which could reshape federal hiring and grant oversight.

HHS Confirms Americans with High-Risk Ebola Exposures Will Have Access to Experimental Therapy MBP-134

HHS has confirmed that Americans with high-risk Ebola exposures in the current Central African outbreak will have access to the experimental monoclonal antibody treatment MBP-134 from Mapp Biopharmaceuticals. This decision, based on promising animal data, signals a potential shift in emergency use policy and creates competitive benchmarking opportunities for pharma teams.

FDA Extends Comment Period for Real-Time Clinical Trials Pilot, AI Use in Studies

The FDA has extended the public comment period for its Real-Time Clinical Trials (RTCT) pilot and the associated Request for Information on AI-enabled optimization of early-phase trials. This move signals the agency's commitment to integrating AI into clinical trial oversight, with implications for drug development speed, cost, and regulatory strategy.

Kairos Pharma Highlights CL-741 Acquisition and 2026 Clinical Milestones: A Strategic Analysis for Pharma Decision-Makers

Kairos Pharma has signed a term sheet to acquire CL-741, a clinical-stage oncology asset, and outlined key 2026 milestones including a Phase 1 trial initiation. This article provides a competitive benchmarking analysis for pharma strategists and investors, covering the deal's rationale, pipeline impact, and what to watch next.