Biologics
Sens. Jeanne Shaheen (D-NH) and Susan Collins (R-ME), co-chairs of the Senate Diabetes Caucus, are calling on FDA to improve access to deceased donor islet cell transplantation for certain individuals with Type 1 diabetes (T1D). In a letter to FDA acting commissioner Kyle Diamantas, the senators say
Biologics
Sen. Ron Johnson (R-WI) has launched a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from HHS, FDA and CDC related to internal discussions about adding a warning for "myocarditis with fatal outcomes" to mRNA Covid-19 vaccine labeling. In a 6/
Biologics
FDA has reversed course and has told UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accelerated approval for the investigational Huntington's disease gene therapy. The regulatory feedback was provided during a recent Type
Biologics
FDA has accepted for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for treating neovascular age-related macular degeneration, commonly known as wet AMD. The filing focuses on the review of product labeling and represents what the company described as the final step
Biologics
An FDA briefing document released in advance of a 6/18 advisory committee meeting reviewing Moderna's investigational mRNA influenza vaccine, mFlusiva (mRNA-1010), reveals a more favorable outlook than many observers expected after a February Refusal-to-File letter was issued and then reversed shortly thereafter. That application
Biologics
FDA has approved a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucentis. Ranluspec references Lucentis, a vascular endothelial growth factor (VEGF) inhibitor widely used in ophthalmology to treat vision-threatening retinal diseases. The biosimilar is approved for the same major indications
Biologics
Former FDAer Peter Pitts, now president of the Center for Medicine in the Public Interest, writes that ALS (amyotrophic lateral sclerosis) “has become an important stress test for whether American regulatory institutions can adapt to 21st century biomedical science.” Writing in an open-source article in the Journal of the
Biologics
FDA has ordered Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition of a Boxed Warning, after the agency and the company failed to reach agreement on how to address concerns about potentially life-threatening immune reactions. In a just-posted 5/20
Biologics
FDA has issued a new set of frequently asked questions (FAQ) aimed at helping companies navigate the electronic submission process for products regulated by CBER, offering additional guidance on technical requirements, acknowledgment timelines, and common causes of submission rejections. The FAQ document addresses recurring issues encountered by sponsors submitting biologics
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