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WASHINGTON, D.C. — The Food and Drug Administration proposed easing registration requirements for distributed drug manufacturing networks last week while expanding oversight of foreign facilities that supply ingredients entering the …
FDA Plan Would Cut Drug Factory Registration Burdens Read More
WAYNE, PA — Palvella Therapeutics (Nasdaq: PVLA) has submitted the first portion of its application seeking U.S. approval of QTORIN rapamycin, a treatment for microcystic lymphatic malformations, moving the company …
Palvella Begins FDA Filing for Rare Disease Drug Candidate Read More
BALA CYNWYD, PA — Larimar Therapeutics, Inc. has begun a rolling application for accelerated U.S. approval of its experimental Friedreich’s ataxia treatment, positioning the biotechnology company to potentially launch the …
Larimar Starts FDA Filing for FA Drug With Mid-2027 Goal Read More
WASHINGTON, D.C. — Federal health officials backed the Drug Enforcement Administration’s move to begin temporarily placing certain kratom-related substances into Schedule I, escalating federal action against concentrated and synthetic products …
DEA Moves to Temporarily Schedule Kratom-Related Opioids Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has expanded approval of the gene therapy Casgevy to include children as young as 2 with sickle cell disease or transfusion-dependent …
FDA Expands Casgevy Approval to Children as Young as 2 Read More
TELFORD, PA — Draeger, Inc. has received U.S. Food and Drug Administration clearance for new software enhancements to its Evita V800 ventilator, adding features designed to support the treatment of …
FDA Clears New Draeger Ventilator Features for Lung Disease Care Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration has proposed requiring foreign tobacco manufacturers to register their facilities and disclose detailed product information, a move aimed at strengthening enforcement …
FDA Proposes Rule to Expand Oversight of Foreign Tobacco Products Read More WAYNE, PA — Palvella Therapeutics (Nasdaq: PVLA) has received U.S. Food and Drug Administration authorization for rolling review of its New Drug Application for QTORIN rapamycin, a step that could …
Palvella Secures FDA Rolling Review for Rare Disease Drug Read More
WILMINGTON, DE — NRx Pharmaceuticals (Nasdaq: NRXP) said the U.S. Food and Drug Administration has authorized an Expanded Access Protocol for its investigational depression treatment NRX-101, potentially allowing certain patients …
FDA Clears Expanded Access Path for NRx Depression Therapy Read More
PHILADELPHIA, PA — GSK (LSE: GSK; NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) said the U.S. Food and Drug Administration has approved Utebzi, the first oral carbapenem antibiotic for adults …
FDA Clears GSK Antibiotic for Drug-Resistant UTI Patients Read More