Topic
FDA Approval
201 published works
Drug & Device Law
FDA’s Draft Guidance on Demonstrating Substantial Evidence of Effectiveness
By Lisa Baird
These days, even the ordinary lay press writes a fair amount about what is, and is not, good science. You would have to have a worm in your brain to…
Big Molecule Watch
AbbVie Submits Regulatory Application to EMA for Subcutaneous SKYRIZI®
By Emma Murray
On August 27, 2026, AbbVie announced that it submitted an application to the European Medicines Agency (“EMA”) seeking approval for SKYRIZI® (risankizumab) for subcutaneous (“SC”) induction for the treatment of…
Big Molecule Watch
FDA approves Regeneron’s PASATRU™ (garetosmab-grts) for Fibrodysplasia Ossificans Progressiva
On August 19, 2026, the U.S. Food and Drug Administration approved Regeneron’s PASATRU (garetosmab-grts) for the treatment of adults with fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder characterized by…
Big Molecule Watch
Biocon Announces Supplemental U.S. FDA Approval for Prefilled Autoinjector for YESINTEK
On August 18, 2026, Biocon Ltd. (“Biocon”) announced that its U.S. subsidiary has received supplemental U.S. FDA approval for YESINTEK® (ustekinumab-kfce) in a single-dose prefilled autoinjector, 45 mg/0.5 mL and…
Big Molecule Watch
FDA Approves Moderna’s mFLUSIVA (mRNA-1010) Seasonal Influenza Vaccine
By Grace Truong
On August 5, 2026, Moderna announced that the FDA approved mFLUSIVA (mRNA-1010), a new seasonal influenza vaccine, for use in all adults 50 years of age and older. As we…
Big Molecule Watch
FDA Approves Orca Bio’s TREGZI for Allogeneic Hematopoietic Transplants
By Alice Yoon
On June 30, 2026, Orca Bio announced that the U.S. Food and Drug Administration (“FDA”) approved TREGZI for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen,…
Big Molecule Watch
Celltrion and Teva’s TRUXIMA® Becomes First Interchangeable Rituximab Biosimilar in U.S.
By Riley Wyberg
On July 1, 2026, Celltrion announced that the FDA had granted interchangeability designation to TRUXIMA® (rituximab-abbs), Celltrion and Teva’s biosimilar to Genentech’s RITUXAN®. With this designation, TRUXIMA® became the first…
Patent Law Weblog
Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (2026)
By Kevin E. Noonan – In a decision that, in retrospect, is not surprising (in view of the haste with which the Court took up the case after granting certiorari;…
Big Molecule Watch
Boan Biotech Submits BLA to FDA for Two Denosumab Biosimilars
By Alice Yoon
On May 29, 2026, Boan Biotech announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for BA6101 (denosumab; injection 60 mg) and…
Big Molecule Watch
FDA Approves Shanghai Henlius Biotech IND for Cetuximab Biosimilar
On May 10, 2026, Shanghai Henlius Biotech announced that the FDA has approved its IND for a proposed biosimilar, HLX05-N, to Eli Lilly’s ERBITUX (cetuximab) product for the treatment of metastatic…