Biologics
Valneva says it has voluntarily withdrawn its BLA for Ixchiq, the company’s chikungunya vaccine, based on FDA safety-related restrictions on the product. In 8/2025, CBER suspended Valneva’s BLA due to serious safety concerns that the vaccine could be causing chikungunya-like illness in vaccine recipients. The
Drugs
FDA has accepted for priority review a Celcuity NDA for gedatolisib in patients with hormone receptor–positive, HER2-negative, PIK3CA wild-type advanced breast cancer. The company says the submission is based on data from the PIK3CA wild-type cohort of Celcuity’s Phase 3 VIKTORIA-1 trial, which evaluated
Drugs
FDA inspectors cited Oklahoma-based outsourcing facility Qualgen for a wide range of manufacturing and quality control failures during a recent inspection, including inadequate controls to prevent cross-contamination of hazardous drugs and repeated lapses previously flagged by the agency. According to an FDA Form 483 issued at the conclusion
Drugs
The U.S. Supreme Court has agreed to hear a patent-infringement dispute between generic drugmaker Hikma Pharmaceuticals USA, Inc. and brand-name company Amarin to decide whether generic drugmakers may face liability for inducement of patent infringement when they market a drug under a so-called “skinny label” — i.
Drugs
Former FDA oncology drug leader Richard Pazdur said concerns surrounding a controversial fast-track drug review initiative under commissioner Marty Makary reflect deeper problems inside the agency, including politicization of regulatory decisions, diminished transparency, and disregard for scientific staff — issues that ultimately led to his departure from the agency late
Devices
FDA is alerting healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after manufacturer Vantive warned that a key component may become dislodged during treatment. In an agency early alert, Vantive is said to have notified customers that updated use instructions are needed
Drugs
FDA has lifted a clinical hold against GH Research’s investigational antidepressant GH001, clearing the way for patient enrollment in the U.S. and advancing plans for a global late-stage development program. The action allows the clinical-stage biotechnology company to resume U.S. trials under its IND and
Drugs
FDA has granted Novartis a breakthrough therapy designation to its experimental antibody ianalumab for treating Sjogren’s disease, a move that could speed development and regulatory review for a condition with no approved targeted therapies. The designation was based on clinical data from multiple studies, including replicate Phase 3 trials,
Drugs
Johnson & Johnson is reporting positive results from a late-stage clinical trial showing that its bispecific antibody therapy Tecvayli (teclistamab-cqyv) significantly improved survival outcomes compared with standard treatments in patients with relapsed or refractory multiple myeloma, including those who had failed commonly used therapies. The Phase 3 MajesTEC-
Biologics
Scholar Rock says it is planning to resubmit this year its BLA seeking approval of apitegromab, a first-in-class muscle-targeted therapy for spinal muscular atrophy (SMA). In 9/2025, FDA issued a complete response letter that cited observations made during an FDA inspection of Catalent Indiana, a third-
Drugs
CBER has published a Standard Operating Policy and Procedure (SOPP) on “Administrative Processing and Review Management Procedures for Investigational New Drug Applications.” The SOPP applies to INDs received by CBER, including those for expanded access, except for individual emergency use requests. It does not address the specific content of scientific
Drugs
Strive Specialties, a compounding pharmacy headquartered in Arizona with offices, staff, and customers in Texas, has filed a lawsuit in a Texas federal court, charging that Eli Lilly and Novo Nordisk are violating antitrust laws in their marketing of glucagon-like peptide 1 agonist (GLP-1) drugs, which are indicated
Drugs
FDA has cited Biocon Biologics Limited for a series of manufacturing and quality control deficiencies following an inspection of the company’s drug substance manufacturing facility in Bengaluru, India, according to a just-posted FDA Form 483. The inspection, conducted between 8/26 to 9/3/2025, identified multiple concerns
Drugs
FDA has released the form FDA-483 with eight observations from an 11/10-11/21/2025 inspection at the Shilpa Medicare drug manufacturing facility in Polepally, Jadcherla, Telangana, India. The specific observations were: * failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to
Drugs
Rep. Raja Krishnamoorthi (D-IL), ranking member of the House Select Committee on the Strategic Competition Between the U.S. and the Chinese Communist Party, has written to three Chinese drug companies requesting detailed information about their manufacturing, labeling, and exporting of glucagon-like peptide-1 weight loss drugs and
Devices
FDA has cleared a BD 510(k) for its EnCor EnCompass Breast Biopsy and Tissue Removal System, a new platform designed to allow clinicians to perform breast biopsies across multiple imaging modalities. The company says the device is intended to support the diagnosis of breast disease by giving providers greater
Drugs
FDA has delayed its review of Sanofi’s diabetes drug Tzield (teplizumab-mzwv) and Disc Medicine’s blood disorder medication bitopertin due to safety and efficacy concerns. An exclusive Reuters story says both drugs were being reviewed as part of the new Commissioner’s National Priority Voucher Program, which promised
Drugs
In a significant deal that underscores the rising valuation of regulatory fast-tracks in the biopharma sector, Jazz Pharmaceuticals announced it has sold its FDA Priority Review Voucher (PRV) for $200 million to an undisclosed purchaser. The transaction was disclosed during Jazz’s presentation at the J.P. Morgan Healthcare
Devices
FDA has cleared an iotaMotion 510(k) for an expanded pediatric indication for its iotaSOFT robotic-assisted cochlear implant insertion system, allowing its use in children as young as four years old. The device is designed to standardize and precisely control the insertion of cochlear implant electrodes, a step surgeons
Drugs
Charles River Laboratories has named former FDA principal deputy commissioner Namandjé N. Bumpus as senior vice president and chief scientific and innovation officer. In this role, Bumpus will lead the company’s scientific strategy, oversee research and development initiatives, and advance innovation to support clients in accelerating the drug development
Drugs
FDA has issued an untitled letter to Altor BioScience, an indirect wholly owned subsidiary of ImmunityBio, alleging that promotional Web pages for bladder cancer drug Anktiva (nogapendekin alfa inbakicept-pmln) are false or misleading and violate federal law. In the just-posted letter, CDER’s Office of Prescription Drug Promotion
Drugs
Following several months of collaboration, FDA and the European Medicines Agency have published a document outlining 10 guiding principles for good artificial intelligence (AI) practice in drug development. An FDA statement says the “integration of AI in drug development has the potential to transform the way drugs are developed and