Biologics
At the 12/3/2025 public meeting on the BsUFA 4 reauthorization, several industry representatives presented their recommendations for matters to be considered in the reauthorization negotiations. CMC regulatory expert Fabiola Gomez (Hyman, Phelps & McNamara) outlines the recommendations in her firm’s FDA Law Blog. The Biosimilar Forum urged
Biologics
FDA has set a PDUFA action date of 10/30 for its review of an Inovio BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis (RRP). A company statement says the BLA was filed under the Accelerated Approval pathway. Inovio says the agency acceptance letter
Biologics
FDA has cited a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and material controls, including failures to assess worst-case conditions for batches later used in the production of widely used vaccines. The just-posted FDA Form 483 followed an inspection conducted from 1/23
Biologics
FDA has issued two separate Form 483 inspection reports citing a range of quality and compliance deficiencies at Catalent Maryland, Inc., highlighting ongoing challenges in the company’s contract biologics and gene therapy manufacturing. The inspections, conducted in April at the company’s Baltimore and Harmans, MD, facilities, identified multiple
Biologics
Sen. Ron Johnson (R-WI) is demanding that FDA turn over records related to an internal review that linked Covid-19 vaccinations to the deaths of at least 10 children, escalating a long-running Republican investigation into vaccine safety and federal oversight during the Biden administration. In a 12/15
Biologics
A 3/31-4/6 FDA inspection at the Microvascular Tissue facility in San Diego, CA, determined that the company’s mVASC, derived from hypodermis recovered from donors and marketed for allogenic use, is an unapproved new drug and an unlicensed biological product. A 12/3 Warning Letter says the
Biologics
FDA has “no plans” to add a Black Box Warning to Covid vaccines, FDA commissioner Marty Makary said in a Bloomberg TV interview, emphasizing that the agency’s focus is on transparency and updated risk assessments rather than broad changes to vaccine policy. Makary said the FDA’s safety and
Biologics
Vanda Pharmaceuticals has filed a BLA for imsidolimab and its use in treating generalized pustular psoriasis, a rare and potentially fatal inflammatory skin disease with no broadly effective long-term therapies. The disorder is driven in many cases by mutations in the IL36RN gene that disrupt the body’s natural
Biologics
FDA is preparing to add a Boxed Warning — the agency’s most stringent safety alert — to Covid-19 vaccines, according to two people familiar with the deliberations. The potential move marks a dramatic escalation in the Trump administration’s ongoing campaign to scrutinize and restrict use of the vaccines, which
Biologics
FDA has approved Amgen’s Uplizna (inebilizumab-cdon) for adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) or anti-MuSK antibodies, giving patients a new twice-yearly biologic option aimed at sustained disease control. Uplizna, already approved for treating neuromyelitis optica spectrum disorder (NMOSD)
Biologics
FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) and its use in combination with AVD chemotherapy for adults and adolescents with previously untreated Stage III or IV classical Hodgkin lymphoma. The agency set a user fee review action date of 4/8/2026.
Biologics
A 6/2-6/6 FDA inspection at Lux Therapeutics, doing business as Ponya Therapeutics, in Brookhaven, GA, documented significant violations of the regulations for human cells, tissues, and cellular and tissue-based products (HCT/P). An 11/25 Warning Letter says the specific violations were: * failure to validate and
Biologics
Children’s Health Defense (CHD), which was co-founded by now-HHS secretary Robert F. Kennedy, Jr., is petitioning FDA to take several actions against the mRNA Covid-19 vaccines produced by Moderna and Pfizer/BioNTech. The petition specifically asks that the agency: * revoke all BLAs for every mRNA Covid-
Biologics
FDA is signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on single-arm studies toward randomized controlled trials (RCTs) that demonstrate superiority over existing treatments. Writing in a new JAMA Perspective piece, CBER director Vinay Prasad and other Center officials say that many
Biologics
The FDA has opened a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines, expanding a review that previously appeared focused only on pediatric cases. The agency says multiple divisions are now examining deaths “potentially related to Covid vaccines” across all age groups,
Biologics
A leading biosimilars scholar has filed an extensive citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval requirements, arguing that current regulations impose unnecessary clinical testing, inflate development costs, and delay access to lower-cost biologic products. The petition, submitted by Sarfaraz K. Niazi, an adjunct professor
Biologics
FDA has approved Gamida Cell’s Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia (SAA), a rare and life-threatening bone marrow disorder. The action expands the use of Omisirge to adults and children as young as six who lack a compatible stem cell donor
Biologics
CDC’s Advisory Committee on Immunization Practices (ACIP) has voted 8 to 3 to discontinue the longstanding policy that all newborns receive the Hepatitis B vaccine within 24 hours of birth — a recommendation in place since 1991. Under the new CDC guidance, only infants born to mothers with a positive
Biologics
CBER director Vinay Prasad addressed a 12/4 closed-door investor conference in New York and defended his leadership and attributed criticism to "misleading media narratives," according to a report by STAT News. His appearance comes the day after 12 former FDA commissioners issued an extraordinary public warning,
Biologics
CBER says that a common deficiency that is driving a significant share of BLA-related complete response letters (CRLs) is manufacturing facility readiness, and companies are routinely misjudging when their facilities are actually prepared for an FDA inspection. In remarks delivered to the Food and Drug Law Institute’s annual
Biologics
Capricor Therapeutics says Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duchenne muscular dystrophy (DMD), achieved statistically significant improvements in both skeletal muscle function and heart performance in the pivotal Phase 3 HOPE-3 trial. Data from the trial will support a response to a complete response letter (CRL)
Biologics
Leading vaccine experts are sharply criticizing a newly revealed FDA memo that claims ten children died “after and because of” receiving Covid-19 vaccines between 2021 and 2024. The memo, written by CBER director Vinay Prasad and obtained by several media outlets, states that the deaths were drawn from reports