Biologics
Replimune plans to resubmit for the third time its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment for advanced melanoma following what the company described as productive discussions with the agency. It says FDA had aligned with Replimune on a path forward for reconsideration of
Biologics
Reps. Debbie Dingell (D-MI) and Rich McCormick (R-GA) are calling on FDA to adopt a more effective strategy for identifying sepsis in human tissue donors. In a 5/26 letter to acting commissioner Kyle Diamantas, Dingell and McCormick say they have learned from talking with experts that screening
Biologics
FDA’s Vaccines and Related Biological Products Advisory Committee has voted 8 to 0 to recommend updating Covid-19 vaccines for the 2026-2027 immunization season to target the currently dominant XFG variant, a descendant of the JN.1 lineage that now accounts for the majority of U.S. Covid
Biologics
Eli Lilly says it is acquiring three vaccine developers in deals worth up to $3.8 billion combined, expanding its push into infectious disease prevention and underscoring a renewed emphasis on vaccines following the hiring of former FDA CBER director Peter Marks late last year. Financial analysts said the acquisitions
FDA Policy/General
The long-term impact of the Supreme Court’s Loper Bright decision in the health landscape remains unclear, according to an article in the Yale Journal on Regulation. Immediately after the decision was announced, many commentators warned of a coming “seismic” impact. Written by staff and a student at the
Biologics
FDA is announcing a 6/18 advisory committee meeting to review Moderna’s mRNA-based seasonal influenza vaccine. The Vaccines and Related Biological Products Advisory Committee is scheduled to review Moderna’s MFLUSIVA (influenza vaccine, mRNA) for preventing influenza disease caused by influenza virus subtypes A and B represented in
Biologics
HHS secretary Robert F. Kennedy Jr. is facing renewed scrutiny from Senate Democrats over the role of longtime anti-vaccine activist David Geier at the Department, as lawmakers say the agency has failed to provide details about his employment despite earlier promises to do so. According to a 2/21
Biologics
FDA has to create a protocol to review Intellia Therapeutics’ nex-z, a permanent, single-dose genomic edit in 60,000 base pairs of a living patient’s hepatocytes that targets transthyretin amyloidosis (ATTR). An online Clinical Trial Vanguard post says the therapy uses liquid nanoparticles to deliver CRISPR-Cas9
Biologics
FDA has accepted for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guerin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease but without carcinoma in situ (CIS). The agency has
Biologics
FDA is facing renewed scrutiny of an internal FDA analysis of pediatric deaths reported after Covid-19 vaccination, following the release of documents by Senator Ron Johnson (R-WI) that he says show federal health officials failed to fully disclose vaccine safety concerns. The controversy centers on a 12/2025
Biologics
Democratic leaders on the House Energy and Commerce Committee are accusing HHS secretary Robert F. Kennedy Jr. of suppressing scientific research supporting the safety and effectiveness of Covid-19 vaccines, escalating a growing political fight over vaccine policy inside federal health agencies. In a letter sent Thursday, senior committee Democrats
Biologics
FDA has approved a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion whose disease has progressed following prior systemic therapy. The monoclonal antibody is designed to target the extremely rare and aggressive form of bile duct
Biologics
CBER acting director Katherine Szarama outlined an expansive vision for the biologics center during remarks at the Food and Drug Law Institute’s annual conference in Washington, DC 5/6, emphasizing regulatory flexibility, scientific rigor and increased engagement with industry as the agency confronts a rapidly expanding pipeline of complex
Biologics
A series of recent FDA regulatory decisions is sharpening focus on the evidentiary standards underpinning cell and gene therapy development, as sponsors face increasing difficulty translating early promise into approvable data packages — an issue highlighted in a recent opinion piece by Jenna DiRito, co-founder and chief operating officer of
Biologics
FDA is planning a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy products. The CBER virtual session will feature regulatory experts addressing common questions about BLA readiness and submission strategies. Officials from the Office of Review Management
Biologics
FDA has cited significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including deficiencies in sterile processing, environmental monitoring, and facility maintenance. The observations were detailed in a just-released FDA Form 483 issued following an inspection conducted last year at the company’s
Biologics
FDA is still weighing candidates to lead CBER as controversial director Vinay Prasad prepares to leave the agency at the end of the month. FDA commissioner Marty Makary says a decision is expected “in the coming weeks,” according to reporting from Reuters. Makary had previously indicated a successor would be
Biologics
Intellia Therapeutics has begun a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z, as a one-time treatment for hereditary angioedema (HAE). The company expects to complete submission in the second half of the year and, if approved, launch the therapy in the first
Biologics
FDA has issued AbbVie a complete response letter for its BLA for trenibotulinumtoxinE, an investigational, fast-acting botulinum toxin intended for aesthetic use. The agency’s letter focused on manufacturing-related issues and did not cite concerns related to safety or efficacy, according to the company. Importantly, FDA did not
Biologics
FDA cited multiple manufacturing and quality control concerns at a Swiss drug substance facility operated by Lonza Group, following an inspection in late 2025, according to a just-posted agency inspection report. The findings, detailed in a highly redacted Form 483 issued to the company’s Visp site, identify deficiencies
Biologics
FDA has accepted a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus (SLE). The agency is expected to make a decision by December. If approved, Gazyva, which is already approved for lupus nephritis, could become the first anti-CD20 therapy specifically indicated for
Biologics
Prominent ophthalmologist and biotech executive Houman Hemmati is reportedly being considered as CBER’s next director to oversee vaccines and gene/cell therapies. The board-certified eye surgeon and frequent commentator on Fox News, if selected, would replace Vinay Prasad, whose controversial tenure comes to an end later this month