Daily biotech intelligence: FDA actions, drug recalls, and recent research.
CALCIUM ACETATE — Approved Sponsor: CHARTWELL MOLECULAR · Application type: SUPPL · Date: 20260501 · Priority: STANDARD
LEVOTHYROXINE SODIUM — Approved Sponsor: CEDIPROF INC · Application type: SUPPL · Date: 20031208 · Priority: STANDARD
PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) — Approved Sponsor: HOSPIRA · Application type: SUPPL · Date: 20130617 · Priority: PRIORITY
LEUCOVORIN CALCIUM — Approved Sponsor: EPIC PHARMA LLC · Application type: ORIG · Date: 19970828
LEUCOVORIN CALCIUM — Approved Sponsor: LEADING · Application type: ORIG · Date: 20201022 · Priority: STANDARD
CHILDRENS ADVIL (IBUPROFEN) — Approved Sponsor: HALEON US HOLDINGS · Application type: SUPPL · Date: 20080611 · Priority: STANDARD
Unknown — Approved Sponsor: CAPLIN · Application type: ORIG · Date: 20260504 · Priority: STANDARD
The Harvard Drug Group LLC [Class II] — 20260429 Product: Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per Reason: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
B BRAUN MEDICAL INC [Class II] — 20260429 Product: DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18 Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Leading Pharma, LLC [Class II] — 20260429 Product: Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Reason: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Premier Dental Products Co [Class III] — 20260429 Product: Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Reason: Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (202
B BRAUN MEDICAL INC [Class II] — 20260429 Product: LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 1 Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Why we left the FDA: Six former officials share their stories (STAT News) In this week's STATus Report, hear from six former FDA officials on why they left the agency.
Opinion: STAT+: Medicare’s new RAPID pathway is a breakthrough for adults. Children are still waiting (STAT News) “The pediatric and orphan pipeline is already the smallest, slowest, and least capitalized segment of the device industry,” writes Kolaleh Eskandanian.
Opinion: We need more men in nursing (STAT News) Men make up just 12% of nurses nationally. That needs to change.
Fraudulent citations, blamed on AI hallucinations, are becoming more common in research papers (STAT News) “Fabricated” citations that do not reference real academic papers are spreading in the literature, polluting the public record of science, a new study found
Key takeaways from WHO briefing on hantavirus cruise ship outbreak (STAT News) Here are key takeaways from a WHO briefing on the hantavirus outbreak aboard a cruise ship.
Seaport’s IPO adventure, obesity pill battles, and Makary’s troubles (STAT News) This week on "The Readout LOUD" podcast: Seaport Therapeutics’ successful IPO, obesity pill battles, and the FDA commissioner's White House troubles.
Science is becoming less disruptive. Is an aging workforce to blame? (STAT News) Most researchers conduct their more disruptive work early in their careers, but as they age, they tend to abandon that groundbreaking energy
Official leading CDC’s cruise ship program retires (STAT News) The hantavirus outbreak on the MV Hondius has focused the public's attention on cruise ship safety.
STAT+: More political interference at the FDA? (STAT News) A political appointee gets in the way of a Sanofi drug's approval, and more from STAT's D.C. Diagnosis newsletter.
STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more (STAT News) Sanofi asked the FDA to pull teplizumab out of a speedy review voucher program after a political appointee disagreed with staff over its approval
Odyssey, on second try, snags $279M in an IPO (BioPharma Dive) After withdrawing its initial filing last year, the immune drugmaker rebounded and added to a recent run of sizable new biotech stock offerings.
Sarepta tumbles as its gene therapy sales decline further (BioPharma Dive) Even though Elevidys beat Wall Street expectations, analysts expect investor focus to shift toward Sarepta's early-stage RNA drugs.
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.