Topic
FDA Approval
200 published works
Big Molecule Watch
Recent Biologics Decisions at Health Canada
In the last few weeks, Health Canada issued several decisions concerning biologics. On October 17, Health Canada approved, via a Notice of Compliance, Biocon Biologics Ltd.’s YESINTEK (ustekinumab injection) and…
Big Molecule Watch
FDA REGULATORY APPROVAL UPDATES
On October 17, 2025, Amgen and AstraZeneca announced that the FDA has approved an additional indication for TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with…
BioSlice Blog
MHRA and NICE launch aligned approvals pathway
By Adela Williams, Christopher Bates, Emma Elliston
On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned…
Big Molecule Watch
Bio-Thera Announces Acceptance of BLA for BAT2506 Referencing Johnson & Johnson’s SIMPONI® (Golimumab)
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing…
Health Law Informer
FDA Transparency Push: CRLs Released
On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had…
Big Molecule Watch
FDA Approves Celltrion’s New Pediatric Formulation of STEQEYMA, Expanding Dosing Flexibility
By Yoko Bian
On June 15, 2025, Celltrion announced that the FDA has approved a new 45mg/0.5mL single-dose vial presentation of STEQEYMA (ustekinumab-stba) for subcutaneous injection. The formulation is intended for pediatric patients…
Drug & Device Law
Supplemental Authority
By Bexis
Not too long ago we saw a story in the legal press about a newly filed case in Minnesota where the plaintiff claimed that the FDA was going easy on…
SEC Actions
Pharma Executives Conceal FDA Recommendation Not to File For Approval
One of the things government agencies do is protect the public health. Take for example, the FDA. One of its functions is to test new drugs to ensure that they…
Food Safety News
Outgoing FDA Commissioner Robert Califf discusses agency’s uncertain future
By News Desk
On Jan. 20, Dr. Robert M. Califf bid farewell to his role as Commissioner of the U.S. Food and Drug Administration in a reflective post on X, formerly Twitter, highlighting…
Drug & Device Law
OTC Drug Approval Not for the Courts to Decide
This one seems pretty straightforward to us, but that did not stop plaintiff in Argueta v. Walgreens Company, 2024 WL 5186825 (E.D. Cal. Dec. 20, 2024), from trying to make…