Daily biotech intelligence: FDA actions, drug recalls, and recent research.
FINTEPLA (FENFLURAMINE) — Approved Sponsor: UCB INC · Application type: SUPPL · Date: 20260522 · Priority: N/A
TOFIDENCE (TOCILIZUMAB) — Approved Sponsor: BIOGEN MA · Application type: SUPPL · Date: 20260522
DIFFERIN EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) — Approved Sponsor: GALDERMA LABORATORIES, L.P · Application type: ORIG · Date: 20260522 · Priority: STANDARD
DATROWAY (DATOPOTAMAB DERUXTECAN) — Approved Sponsor: DAIICHI SANKYO INC · Application type: SUPPL · Date: 20260522 · Priority: PRIORITY
HEPCLUDEX (BULEVIRTIDE) — Approved Sponsor: GILEAD SCIENCES INC · Application type: ORIG · Date: 20260522 · Priority: PRIORITY
Oasis Medical, Inc. [Class II] — 20260520 Product: Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured Reason: Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspecti
ENDO USA, Inc. [Class II] — 20260520 Product: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured fo Reason: Presence of particulate matter: identified as Buprenorphine free base
Ascend Laboratories, LLC [Class II] — 20260520 Product: Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufa Reason: Failed Dissolution Specifications
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles [Class II] — 20260513 Product: TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dos Reason: Incorrect Product Formulation: product did not contain insulin as listed in the label.
CareFusion 213, LLC [Class II] — 20260513 Product: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Steri Reason: Lack of assurance of Sterility: potential product contamination
Opinion: I’m a weight-loss doctor. Here’s why I worry about GLP-1 ‘microdoses’ (STAT News) Long term, we don’t know what tiny doses of GLP-1s for cosmetic weight loss can do, writes a weight-loss doctor.
STAT+: The woman behind the world’s biggest longevity competition (STAT News) Jamie Justice of XPRIZE Healthspan on the most promising research and "purely scammy" treatments in the world of longevity.
STAT+: As Ebola outbreak in Central Africa grows, the U.S. turns itself into a fortress (STAT News) The U.S. is taking extraordinary steps to keep Ebola out. But its policies may create risks for Americans infected overseas and discourage volunteers from responding to the outbreak.
STAT+: Biotech veteran Jeremy Levin on why the industry’s future is secure, but American leadership is at risk (STAT News) Biotech is producing scientific breakthroughs that once seemed impossible. But according to longtime industry executive Jeremy Levin, the institutions that support these advances, from regulators, to investors, and even public…
Biotech exec Jeremy Levin on the industry’s strategic turning point (STAT News) This week on "The Readout LOUD," longtime biotech exec Jeremy Levin talks about his new book and the industry's strategic turning point. Listen now.
STAT+: Trump’s pharma deals get tested (STAT News) We still have a lot of questions about Trump's MFN deals with pharma companies.
Opinion: Ebola at the World Cup? Here’s what we should actually worry about (STAT News) “Infectious disease threats during the World Cup will almost certainly look much more familiar than frightening headlines suggest,” writes Krutika Kuppalli.
STAT+: Oura brings rings to the cuffless blood pressure party (STAT News) In this edition of STAT Health Tech: A new wave of blood pressure monitoring wearables, Stanford asking patients about AI, and more.
STAT+: Pharmalittle: We’re reading about a hepatitis B drug, CVS returns Lilly obesity drug to formularies, and more (STAT News) In this morning's Pharmalittle roundup, we're reading about a hepatitis B drug, CVS returns Lilly obesity drug to formularies, and more.
STAT+: Ahead of ASCO, all eyes on pancreatic cancer (STAT News) Strong results from GSK's hepatitis B drug, engineered heart patches, and more biotech news from The Readout
GSK, Ionis unveil data for hepatitis B drug touted as ‘functional cure’ (BioPharma Dive) The findings supporting bepirovirsen were deemed a “historic moment” by physicians and validate a drug that has “clear blockbuster potential,” according to one analyst.
CVS obesity drug deal puts Lilly on equal footing with Novo (BioPharma Dive) The agreement includes Lilly’s new pill Foundayo and restores coverage for Zepbound, erasing what had been a commercial edge for rival Novo Nordisk.
This briefing is compiled automatically from FDA public APIs (openFDA), arXiv, and industry RSS feeds (STAT News, Fierce Biotech, BioPharma Dive, Nature, Science News). Not investment advice. Verify all data before making any decisions.