WASHINGTON, March 10, 2026 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)1, a sweeping guidance that codifies multiple regulatory modernization proposals first advanced by Professor Sarfaraz K. Niazi, pharmaceutical scientist, Adjunct Professor at the University of Illinois Chicago (College of Pharmacy), and regulatory advisor to the FDA, EMA, and MHRA. The guidance is projected to red

iStock, Marcos Silva Industry groups have identified upfront costs as a barrier to streamlining U.S. drugmaking. The nonprofit API Innovation Center has a proposed answer for how to tilt finances in favor of investments in continuous manufacturing. As the White House began ratcheting up pressure on drugmakers to reshore manufacturing last summer, President Donald Trump’s senior counselor for trade and manufacturing, Peter Navarro, outlined a plan to go beyond changing where medicines are made

iStock, ojogabonitoo Single-trial approvals are raising the bar on trial design and execution. The new paradigm is pushing sponsors to plan earlier, step up their data and risk‑based quality management and use modeling and AI to generate one compelling, regulator‑ready evidence package. In the wake of the recent FDA decision to move from a requirement of two pivotal trials to one for new drug applications, sponsors now face higher stakes. They include maintaining patient safety and enabling s

JUPITER, Fla., March 9, 2026 /PRNewswire/ -- Myosin Therapeutics today announced it has been invited to present at two upcoming South Florida life sciences events highlighting emerging biotechnology innovation and regional industry growth. On March 10, the company will participate in the Investival Showcase: South Florida – The Rising Life Science Hub, and on March 24, Myosin will present in the Cornerstone Session: Innovation at BioFlorida's South Florida Life Sciences Showcase. The invitati

NORTHRIDGE, Calif., March 9, 2026 /PRNewswire/ -- MiniMed Group, Inc. (MiniMed; Nasdaq: MMED) today announced the closing of its previously announced initial public offering (IPO) of 28,000,000 shares of its common stock at a price to the public of $20.00 per share. The shares began trading on the Nasdaq Global Select Market (Nasdaq) on March 6, 2026 under the symbol "MMED." As of the closing of the IPO, Medtronic plc (Medtronic) owns approximately 90.03% of MiniMed common stock. Medtronic has p

Dunwoody Recovery Place offers comprehensive addiction treatment, alcohol detox, and relapse prevention therapy for adults across Atlanta and Georgia. Comprehensive treatment and supervised detox provide adults with the structure, care, and tools needed for lasting recovery.” — Dunwoody Recovery Place Clinical Team ATLANTA, GA, UNITED STATES, March 9, 2026 / EINPresswire.com / -- Dunwoody Recovery Place, a leading addiction treatment center in Atlanta , Georgia, is expanding access to evidence-b

WHITE PLAINS, N.Y., March 9, 2026 /PRNewswire/ -- If you purchased or paid for some or all of the purchase price of Amitiza and/or generic versions of Amitiza (Lubiprostone) as a third-party payor, a class action lawsuit may affect your rights. Your rights may be affected by a class action lawsuit regarding the price paid for brand and generic Amitiza by third-party payors filed against Defendants Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceuti

SHINKEI THERAPEUTICS RECEIVES FDA CLEARANCE TO PROCEED WITH PHASE 1 CLINICAL TRIAL FOR MR-101 AND COMPLETES PHASE 2 CLINICAL TRIAL FOR MR-301 IN SEVERE TBI PRINCETON, NJ, UNITED STATES, March 9, 2026 / EINPresswire.com / -- SHINKEI Therapeutics, Inc., a clinical-stage pharmaceutical company dedicated to the development of novel therapeutics for Central Nervous System (CNS) disorders, today announced two significant milestones in its drug development pipeline: (1) the U.S. Food and Drug Administr

Oral presentation during Presidential Plenary Session to feature the final results of the ARES pivotal Phase 3 trial evaluating MaaT013 in acute Graft‑versus‑Host Disease (aGvHD) with gastrointestinal involvement Poster presentations for: CHRONOS, a multicenter retrospective cohort study describing real-world outcomes in third-line acute gastrointestinal GvHD not treated with microbiotherapy PHOEBUS, a Phase 2b trial, potentially pivotal, evaluating MaaT033 seeking to improve survival after allo

MedTech Innovators Now Live with Future-Ready UDI Compliance We’re proud to see our first customers using UDI Hub to confidently tackle EUDAMED and other regulatory challenges.” — Patrick Pfau, CEO of p36 GmbH BAD HERSFELD, GERMANY, March 9, 2026 / EINPresswire.com / -- p36 GmbH today announced the successful completion of UDI Hub’s development. UDI Hub is now generally available, and the first internationally operating MedTech companies are already managing their UDI data with UDI Hub. The solu