The day after CBER’s Cellular, Tissue, and Gene Therapies Advisory Committee meeting on Capricor Inc.’s Deramiocel for the treatment of cardiomyopathy in DMD, the Advisory Committee met on July 30, 2026, to discuss Replimune’s BLA resubmission seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination …
After more than a year with nary an adcomm (just 2 drug approval-related meetings in the Makary era), CBER’s Cellular, Tissue, and Gene Therapies Advisory Committee meetings came back with a vengeance last week with back-to-back meetings to discuss two seemingly controversial cell and gene …
Keeping with the 2026 pace of issuing at least two letters a month, the Office of Prescription Drug Promotion (OPDP) has issued letters 20 and 21 this July, and it’s pretty clear to these bloggers that these summer letters are the “filler” to keep up …
Well, don’t say we didn’t tell you what was coming. Day 2 of the Pharmacy Compounding Advisory Committee (PCAC or the Panel) Meeting (mostly) followed in the footsteps and at the pace of Day 1 (see our prior coverage of Day 1). Over the course of …
See what we did there? Well, readers, some big things have taken place. “Big things” have happened: we previewed these for you in our two-part FDA’s Pep(tide) Rally! What Compounders and Industry Need to Know blog posts (Part I, Part II). Yesterday, on Day 1 of FDA’s …
Hyman, Phelps & McNamara, P.C. (HPM), the nation’s largest law firm dedicated exclusively to FDA and life sciences law, is pleased to announce that Gayatri Rao, M.D., J.D., M.B.E. has joined the firm as a Director. Dr. Rao brings a rare combination of experience spanning, nearly …
For years, debates over the 340B Drug Pricing Program have played out primarily through litigation, agency guidance, and stakeholder advocacy. Congress, by contrast, has largely remained on the sidelines. That may be changing. Within two weeks, lawmakers in both chambers released significant reform proposals that …
Well, it’s here, it’s happening. The Unified Agenda of Regulations has been updated to include a proposed rule, “Transparency in Direct-to-Consumer Advertising” to remove the (so-called) “adequate provision loophole” from the prescription drug advertising regulations in 21 C.F.R. §202.1(e)(1)(i)(B). The proposal appears to be set …
This third installment of our series analyzing the rider provisions in the fiscal year 2026 appropriations legislation continues our examination of key FDA policy directives embedded in congressional committee reports. This post focuses on provisions related to medical devices, pharmacy compounding, GLP-1 medications, and food-areas …
This is the second in our series analyzing the riders attached to the FY 2026 Labor-HHS Appropriations Bill. This installment examines the drug-related provisions, which cover a wide range of topics from accelerated approval and rare disease therapies to biosimilars and opioid regulation. The Committee’s …
On May 1, 2026, the House Committee on Appropriations submitted House Report 119-632 to accompany H.R. 8646—the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2027, which passed on June 4, 2026. The report serves as the Committee’s …
Listing patent information in the Orange Book is one of the most important things you can do as an innovator sponsor to ensure that your property rights are respected. And, of course, it’s statutorily required. So that makes the new guidance FDA just issued on …
On June 2, 2026, FDA (specifically, CBER) issued a new draft guidance titled “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing” (the “Draft Guidance”). As suggested by the title, the Draft Guidance is primarily intended for sponsors developing gene …
On June 8, 2026, the Department of Defense published its updated list of “Chinese military companies” under Section 1260H of the National Defense Authorization Act for Fiscal Year 2021. Among the entities newly added: WuXi AppTec Co., Ltd., the China-based contract development and manufacturing organization …
The skinny label is back from the dead. While back in 2021, it seemed like the skinny label was effectively dead after the Federal Circuit twice held Teva liable for induced infringement of GSK’s labeling in GSK v. Teva, the Supreme Court breathed new life …
