Biologics
CBER director Vinay Prasad has made recent leadership changes at the Center, appointing several new acting deputy directors and reassigning key staff within the Center. Katherine Szarama has moved from HHS’ Advanced Research Projects Agency for Health to be acting CBER deputy director, according to a MedPage Today report. She
Drugs
The D.C. federal court has rejected a Novartis suit challenging FDA’s approval of MSN’s ANDA for a generic version of Entresto (sacubitril /valsartan) with a carve-out of a patent-protected use. Attorney Sara Koblitz (Hyman, Phelps & McNamara) says MSN carved out a modified dosing regimen
Biologics
A 5/14-5/20/2024 FDA inspection at New Life Medical Services in Lutz, FL, found that the company sells human products derived from umbilical cord, amniotic fluid, and exosomes for allogeneic use. A 9/24 Warning Letter says the firm’s products are legally considered to be unapproved
Drugs
Age Reversal Unity, an advocacy organization founded in 2024 to lobby FDA to reclassify aging as a disease rather than a natural process, is petitioning the agency to create a regulatory pathway for so-called enhanced drugs, which it defines as “substances intended to make humans enhanced and superhuman, including
Biologics
Complement Therapeutics has received the green light from FDA to begin human testing of its lead gene therapy, CTx001, in patients with geographic atrophy secondary to age-related macular degeneration. The IND approval paves the way for the company to launch Opti-GAIN, a Phase 1-3 trial evaluating the
Drugs
Vivace Therapeutics has received an FDA fast track designation for its lead cancer drug VT3989, a first-in-class TEAD autopalmitoylation inhibitor being developed for patients with unresectable malignant mesothelioma that has progressed following treatment with an immune checkpoint inhibitor and platinum-based chemotherapy. Vivace is currently evaluating VT3989 in
Drugs
A 4/28-5/2 FDA inspection at the Naturich Cosmetique drug manufacturing facility in Garland, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/25 Warning Letter says the specific violations were: * failure to establish adequate written procedures for production and process
Devices
FDA says Trividia Health has recalled one lot of 601 True Metrix self-monitoring blood glucose meters co-branded under the Good Neighbor Pharmacy brand and distributed in the U.S. A company statement posted by the agency says the recalled units may have the potential for defective LCD displays
Drugs
FDA has issued Xspray Pharma a complete response letter on its NDA for Dasynoc (dasatinib) and its use for treating chronic myeloid leukemia and acute lymphoblastic leukemia. The letter cited GMP deviations at the company’s contract manufacturer, according to an Xspray release. The GMP issues do not involve Xspray’
Drugs
A federal judge has handed Eli Lilly a partial win in a lawsuit challenging FDA’s refusal to classify retatrutide — the company’s investigational obesity therapy — as a biological product. The U.S. District Court for the Southern District of Indiana ruled that while the agency acted lawfully in concluding
Drugs
AstraZeneca says its investigational drug baxdrostat met the primary endpoint in the Phase 3 Bax24 trial, showing a statistically significant and clinically meaningful reduction in 24-hour ambulatory systolic blood pressure compared with placebo in patients with resistant hypertension. The 12-week study found that baxdrostat significantly lowered blood pressure
Drugs
Thirteen Republican members of the House are calling on HHS secretary Robert F. Kennedy, Jr., to consider laying off CDER director George Tidmarsh, Office of Generic Drugs director Kathleen Uhl, and other agency staffers responsible for the recent approval of a generic form of the medical abortion drug mifepristone. In
Devices
FDA has given Nobles Medical Technology II the green light to restart its pivotal clinical trial evaluating the NobleStitch EL system, a device-free, suture-mediated method for closing a patent foramen ovale (PFO) to reduce recurrent cryptogenic stroke. The trial was paused in 2023 over a protocol update to
Drugs
FDA has approved a Boehringer Ingelheim NDA for Jascayd (nerandomilast) tablets for treating idiopathic pulmonary fibrosis (IPF). The oral phosphodiesterase 4B (PDE4B) inhibitor was approved based on results from two randomized, double-blind, placebo-controlled trials showing that Jascayd significantly slowed lung function decline compared with placebo, according to an
Drugs
In a Food & Drug Law Institute review of Warning Letters (WLs) issued by FDA since 1/9/2020, a Hyman, Phelps & McNamara attorney and a regulatory expert say Tuesdays are the most common day for a WL to appear on the FDA Web site. The analysis found that
Devices
A 4/9-4/21/2025 FDA inspection at Technological Medical Advancements in West Palm Beach, FL, identified multiple violations in the firm’s manufacturing of two unapproved laser systems. A 9/26 Warning Letter says specific Quality System Regulation violations were: * failure to adequately establish procedures to ensure that
Drugs
A 3/19-3/25 FDA inspection at the Creative Essences drug manufacturing facility in Santa Fe Springs, CA, found multiple violations, including significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/25 Warning Letter says the specific violations were: * failure to thoroughly investigate any
Biologics
Lexeo Therapeutics says it has received FDA guidance on a potential accelerated approval pathway for its investigational gene therapy LX2006. The agency says FDA indicated it is open to allowing pooled data from ongoing Phase 1-2 trials and a future pivotal study to support a BLA for accelerated approval,
Drugs
Six months after being forced to resign, former CBER director Peter Marks has landed at Lilly Research Laboratories to oversee molecule discovery and infectious disease programs, according to news reports. Marks’ forced resignation in early April marked the beginning of an upheaval at the Center that saw numerous staff leave
Drugs
FDA has lifted a clinical hold on Neurizon Therapeutics on its lead experimental treatment for amyotrophic lateral sclerosis (ALS), clearing the way for Phase 2/3 development of NUZ-001 as part of the HEALEY ALS Platform Trial, which is expected to begin later this quarter. “Supported by our compelling
Drugs
FDA has accepted for priority review an Orca Bio BLA for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes. The agency has set 4/6/2026 as the user fee review action target date. If approved, Orca-T
Devices
FDA has granted IceCure Medical’s de novo marketing authorization for the ProSense cryoablation system for treating early-stage, low-risk breast cancer in women aged 70 years and older who are also receiving adjuvant endocrine therapy. The company says ProSense offers a minimally invasive, outpatient alternative to lumpectomy, using