Makary’s Exit Resurrects Questions About US FDA’s Direction Under Trump Administration
Current and former officials warned the FDA is facing a growing loss of institutional knowledge as the Trump-aligned Make America Healthy Again movement pushes for an agency more focused on food.
Scrip - May 13, 2026

Makary Resigns: Battles Over Flavored Vapes, Abortion Pill Doomed FDA Head
FDA Commissioner Martin Makary ultimately could not overcome White House and special interest anger about some of his policy decisions, including his resistance to approving flavored vaping products.
Medtech Insight - May 12, 2026

Roche’s Alzheimer’s Blood Test Achieves CE Marking, One Day After Fujirebio
Roche’s Elecsys pTau217, co-developed with Eli Lilly, uses a dual-cutoff approach and — unlike Fujirebio’s rival test — is cleared for primary care.
Medtech Insight - May 12, 2026

Makary Out As US FDA Commissioner With Kennedy’s GRAS Change Proposal Still Unfulfilled
HHS Secretary Kennedy and President Trump announce in separate social media posts that Martin Makary, FDA commissioner since March 2025, resigned. FDA Human Foods Program director Kyle Diamantas is acting commissioner.
HBW Insight - May 13, 2026

New Product Launches Drive Celltrion’s Q1 Revenues
Celltrion’s “young” products accounted for 60% of quarterly revenues, with further growth opportunities expected in the second half of 2026.
Generics Bulletin - May 12, 2026

Now That He’s Stepped Down, Will Makary’s Reforms Outlast His Tenure?
Though Marty Makary is out as FDA commissioner, his time at the agency has already reshaped how it operates – from a sweeping integration of generative AI into the review process to a landmark MDUFA VI negotiation that industry veterans describe as the most collaborative in history.
In Vivo - May 12, 2026

Podcast: Inside Arcutis with CEO Frank Watanabe
In this episode of the In Vivo podcast, Arcutis CEO Frank Watanabe talks culture, "patient?is?paramount" leadership, Zoryve's growth in inflammatory skin disease, and how he’s positioning the company for durable innovation and profitability.
In Vivo - May 12, 2026

Skinny Label At SCOTUS: Could Generics Maintain Carve-Out Authority No Matter The Decision?
Hikma could lose the monumental skinny label carve out case against Amarin at the US Supreme Court, but maintain its and other generic drug sponsors’ ability to market products with patented indications carved out.
In Vivo - May 12, 2026