Latest in FDA & Regulation

223 words

Immune cell shifts track hepatitis B treatment response

The study set out to characterize how NK cell phenotypes, receptor expression and cytokine profiles change during this combination regimen and how those changes relate to clinical outcomes. HBsAg loss remains a major challenge in chronic hepatitis B, and identifying…

finance.yahoo.com
709 words

UCB announces U.S. FDA approval for ZILBRYSQ® (zilucoplan) autoinjector self-administration for adults living with generalized myasthenia gravis

ZILBRYSQ is the first and only macrocyclic peptide C5 inhibitor approved as a self-administered once-daily, subcutaneous autoinjector for adults living with generalized myasthenia gravis (gMG) in the U.S.¹ ZILBRYSQ now offers two self-administration options for adults living with gMG who are anti-acetylcholine…

kttn.com
504 words

Missouri AG challenges Eli Lilly over prescription drug pricing

Missouri Attorney General Catherine Hanaway has issued a cease-and-desist letter to Eli Lilly and Company, ordering the pharmaceutical manufacturer to discontinue requirements that her office alleges unlawfully restrict Missouri hospitals’ access to discounted prescription medications through the federal 340B Drug Pricing…

FDA & Regulation

Regulators, approvals and the rules that shape biotech: FDA decisions and leadership, drug-pricing and trade policy, and regulators abroad.

  • 3 Subtopics
  • 68 Tracked terms
  • Last 30 days Feed window

Inside FDA & Regulation

FDA Approvals FDA approvals and rejections of biotech medicines - drugs, biologics, cell and gene therapies - accelerated approvals and advisory committee votes.
FDA Policy & Leadership How the FDA is run: its commissioners, Vinay Prasad and CBER, drug-center chiefs, priority vouchers, staff cuts and changes to drug review.
Drug Pricing, Tariffs & Policy Policy that moves biotech's business: drug-price negotiation, most-favoured-nation pricing, pharmaceutical tariffs, the BIOSECURE Act and drug-industry lobbying.

What this topic collects on

An article joins this feed when it matches these terms. Each one is also a search of its own.

  • +28 more