Your essential biotech, medtech, and pharma recap — no noise, just what matters.

The FDA is now operating with acting leaders in every senior position that matters for drug and biologics review. Commissioner: acting (Diamantas, food background). CDER director: acting (Davis, third acting head in months). CBER director: acting (Mikhail, former pharma exec who joined the FDA in 2025). Chief of staff: acting (Zeta, promoted from deputy commissioner). The cascade happened in 72 hours. Høeg said on social media that she was fired. Szarama departed after serving just three weeks as CBER head (she replaced Vinay Prasad, who left at the end of April). Traficant was removed from his position but is reportedly staying in an advisory role. Capital Alpha predicted an "unprecedented" and "prolonged" leadership vacuum, adding that the administration "might struggle to find a suitable candidate who will want the job." This is not just a governance problem. It is a capacity problem. Every NDA, BLA, PDUFA action, advisory committee meeting, and emergency authorization (including the Ebola PHEIC response) runs through CDER or CBER. When the people making those decisions are new, acting, and potentially temporary, review timelines risk slowing, institutional knowledge erodes, and regulatory predictability declines. For companies with filings pending or planned (Revolution Medicines, Lilly Foundayo T2D, Teva ecopipam, and dozens of others), the practical question is whether the FDA can maintain review-cycle continuity through this transition. 👉 Read Full Analysis

FDA Loses Three More Senior Leaders in 72 Hours

What Happened: Within days of Commissioner Makary's May 12 resignation, three additional senior leaders departed:

Tracy Beth Høeg (CDER acting director): Fired, according to her own social media post. Høeg had served as acting CDER head since late 2025 after Richard Pazdur departed. She rose to prominence for challenging U.S. vaccine policy during COVID-19. Reuters first reported her departure May 16. She has been replaced by Michael Davis, who had been CDER deputy director for approximately one year.

Katherine Szarama (CBER acting director): Departed after just three weeks in the role. She had replaced Vinay Prasad, who left at the end of April. Szarama is expected to remain at the FDA in another capacity to support product-related issues. Karim Mikhail, a former pharmaceutical executive who joined the FDA in 2025, has been named acting CBER director.

Jim Traficant (Chief of Staff): Removed from his position, according to The Guardian. Traficant had been chair and CEO of Citadel Sciences before joining the FDA in March 2025. He is reportedly staying on in an advisory role. Lowell Zeta, previously deputy commissioner and special counsel, was named acting chief of staff.

Executive Impact: Drug Topics reported that CDER alone has had five different heads in the span of a single year. BioSpace reported that fewer than half of senior FDA leaders from six months ago remain at the agency. Capital Alpha wrote: "Makary oversaw what must be the most damaging period in FDA history." The firm predicted the administration "might struggle to find a suitable candidate who will want the job." PharmExec described the situation as raising "near-term risks for review-cycle continuity, policy coherence, and external stakeholder confidence across drugs, biologics, and vaccines." The FDA's organizational chart was updated on May 16 to reflect the new chain of command.

Relay Therapeutics Outpaces Novartis with 60% Response in Vascular Anomalies RLAY

Relay Therapeutics reported data from the Phase ReInspire trial of zovegalisib in vascular anomalies, showing a 60% response rate, according to BioSpace. BioPharma Dive noted the findings "suggest the therapy could be superior to Novartis' Vijoice at treating 'vascular anomalies,' a cluster of chronic conditions with few available treatments." RLAY shares rose 11.3% in premarket trading on the news. Zovegalisib is a PI3Kα mutant-selective inhibitor, the same target as Vijoice (alpelisib), but designed for improved selectivity that could translate to better tolerability.

BioMarin Suffers Phase 3 Flop in Rare Disease BMRN

BioMarin reported a Phase 3 failure in its rare disease portfolio, according to BioSpace, which described it as "another blow." The specifics of the program and indication were not detailed in initial reports, but the failure adds to a challenging stretch for BioMarin's pipeline. The company has been building its rare disease franchise around Voxzogo (achondroplasia) and Roctavian (hemophilia A gene therapy).

AbbVie Locks Rinvoq Generics Out Until 2037 ABBV

AbbVie reached patent settlements delaying the arrival of generic versions of Rinvoq (upadacitinib) until 2037, according to BioPharma Dive, enabling approximately four additional years of exclusivity. BioPharma Dive reported the drug generated approximately $6B in 2024 sales. The settlement follows the AbbVie playbook used with Humira, which maintained market exclusivity years beyond its original patent expiration through an extensive patent estate and settlement strategy. For AbbVie, which is navigating the post-Humira transition through Skyrizi and Rinvoq growth, extending Rinvoq's exclusivity to 2037 significantly reduces the near-term patent cliff risk.

👉 Read Full Analysis

Six of the most important public health leadership positions in the U.S. government are either vacant or held by acting appointees with limited tenure. CDER has had five heads in one year. PharmExec described this as raising "near-term risks for review-cycle continuity, policy coherence, and external stakeholder confidence."

For companies with pending filings: there is no indication that PDUFA timelines have slipped. The FDA career staff who manage day-to-day review operations remain in place. But institutional leadership sets priorities, resolves disputes between review divisions, and makes final decisions on contentious applications. Without permanent leaders, those decisions take longer or default to the most conservative option.

💊 PI3Kα in Vascular Anomalies

Vascular anomalies are a cluster of rare conditions involving abnormal blood vessel or lymphatic vessel growth. Novartis's Vijoice (alpelisib) was approved in 2022 for PIK3CA-related overgrowth spectrum (PROS), but its use is limited by metabolic side effects (hyperglycemia, rash). Relay's zovegalisib is a mutant-selective PI3Kα inhibitor, designed to target the mutant form of PI3Kα while sparing the wild-type form. This selectivity should reduce the metabolic side effects that limit Vijoice.

The 60% response rate in the ReInspire trial compares favorably to Vijoice's clinical data, though cross-trial comparisons carry limitations. If zovegalisib demonstrates a cleaner safety profile alongside superior or comparable efficacy, it could become the preferred treatment in a space where the current standard has significant tolerability limitations.

📊 AbbVie's IP Fortress

The Rinvoq 2037 settlement extends AbbVie's playbook. With Humira, AbbVie built a patent thicket of 100+ patents and settled with biosimilar challengers to delay competition by years. The same strategy is now protecting Rinvoq.

The math: Rinvoq generated ~$6B in 2024 (BioPharma Dive). Four additional years of exclusivity (2033 original to 2037 settlement) at a conservative growth trajectory could represent $25B+ in protected cumulative revenue. That is the value of patent strategy executed well. For competitors developing JAK inhibitors or next-generation immunology agents, the 2037 date pushes the competitive window further out.

🎯 Catalyst Calendar: May 2026 Forward

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