Daily biotech intelligence: FDA actions, drug recalls, and recent research.
TALVEY (TALQUETAMAB) — Approved Sponsor: JANSSEN BIOTECH · Application type: SUPPL · Date: 20250819 · Priority: N/A
VABRINTY (LEUPROLIDE ACETATE) — Approved Sponsor: TOLMAR · Application type: SUPPL · Date: 20101005 · Priority: UNKNOWN
LEUPROLIDE ACETATE — Approved Sponsor: AMNEAL · Application type: SUPPL · Date: 20260506 · Priority: STANDARD
LEUPROLIDE ACETATE — Approved Sponsor: EUGIA PHARMA · Application type: SUPPL · Date: 20250923 · Priority: STANDARD
OCREVUS (OCRELIZUMAB) — Approved Sponsor: GENENTECH INC · Application type: SUPPL · Date: 20171102 · Priority: STANDARD
ZOLADEX (GOSERELIN) — Approved Sponsor: TERSERA · Application type: SUPPL · Date: 19980727 · Priority: STANDARD
Unknown — Approved Sponsor: TERSERA · Application type: ORIG · Date: 19951218 · Priority: STANDARD
Unknown — Approved Sponsor: ABBVIE ENDOCRINE INC · Application type: SUPPL · Date: 20020516 · Priority: PRIORITY
Thea Pharma, Inc. [Class II] — 20260506 Product: Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Wells Pharma of Houston LLC [Class II] — 20260506 Product: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Reason: cGMP deviations.
Thea Pharma, Inc. [Class II] — 20260506 Product: iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Wells Pharma of Houston LLC [Class II] — 20260506 Product: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well ph Reason: cGMP deviations.
Wells Pharma of Houston LLC [Class II] — 20260506 Product: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg p Reason: cGMP deviations.
STAT+: Scientists link boy’s tumor to gene therapy viruses, in rare finding (STAT News) Doctors have linked a boy's tumor to a gene therapy, but say the rare risks need to be weighed against the profound benefits such medicines can offer.
STAT+: Drug meant to make gene therapy safer may also make it less effective (STAT News) Encoded Therapeutics gives a heads-up to other gene therapy company about the trade-offs with a drug meant to improve safety.
Opinion: RFK Jr.’s antidepressant deprescribing push gets one thing right — and others dangerously wrong (STAT News) “Deprescribing requires gradual tapering, psychological support, careful risk stratification, and accessible alternatives — none of which Kennedy’s initiative provides at scale.”
Opinion: What can ‘blue zones’ really teach us about aging? (STAT News) Have you heard about blue zones where people tend to live much longer? They’re more complicated than they might sound.
Opinion: Access to air conditioning is critical preventive care. But federal policy treats it as optional (STAT News) Access to air conditioning is critical preventive care. But federal policy treats it as optional, write Charles E. Leonard and Anthony Nicome.
STAT+: Bill Cassidy risked his legacy. It may not be enough to save his career (STAT News) Sen. Bill Cassidy risked his legacy. It may not be enough to save his career.
STAT+: A new kind of liver crisis is emerging in the U.S. The American diet is to blame (STAT News) Young people and women are particularly vulnerable to MetALD, a dangerous merging of metabolic disease and alcohol use.
STAT+: Why Marty Makary was the worst FDA commissioner in 25 years (STAT News) Marty Makary, who resigned under pressure from the FDA, brought to the job a fundamental lack of understanding of the nature of the role, STAT's Matthew Herper writes.
Males who discuss suicide seek help less often than females, report finds (STAT News) Out of 1.5 million messages received in 2025, the Crisis Text Line found that less then 20% of the texters identified as male only
STAT+: European Union inks a draft deal to boost local production of medicines and avoid shortages (STAT News) The E.U. reached a provisional deal to strengthen the supply of essential medicines and avoid shortages by boosting domestic production and reducing reliance on imports.
[Podcast] Closing the Distance in Cancer Care (BioPharma Dive) This podcast episode explores the critical role community oncology plays in the U.S. healthcare system and why supporting its growth and autonomy matters for patients and providers.
FDA chief Marty Makary resigns from agency, ending tumultuous tenure (BioPharma Dive) Makary’s exit ends a turbulent run marred by leadership upheaval, mass layoffs, political pressure and public spats with drugmakers.
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.