March 18th, 2026

Silver Spring, MD / CRWE PRESS RELEASE / March 18, 2026 - The U.S. Food and Drug Administration today issued a draft guidance intended to help drug developers validate new approach methodologies (NAMs) to be used instead of animal testing i. Read more

March 10th, 2026

Silver Spring, MD / CRWE PRESS RELEASE / March 10, 2026 - The U.S. Food and Drug Administration today approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric p. Read more

February 12th, 2026

Device Delivers Non-invasive Therapy and Supports Care at Home Silver Spring, MD / CRWE PRESS RELEASE / February 12, 2026 -  The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patient. Read more

February 06th, 2026

Agency also grants two petitions to expand alternative food color options Silver Spring, MD / CRWE PRESS RELEASE / February 05, 2026 - Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nation&. Read more

January 13th, 2026

Silver Spring, MD / CRWE PRESS RELEASE / January 12, 2026 - The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.   “With today&rs. Read more

December 13th, 2025

Approvals Are for Uncomplicated Urogenital Gonorrhea Silver Spring, MD / CRWE PRESS RELEASE / December 12, 2025 - The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection calle. Read more

December 04th, 2025

Silver Spring, MD / CRWE PRESS RELEASE / December 3, 2025 - The U.S. Food and Drug Administration today granted approval for Avance (acellular nerve allograft-arwx) in surgical implantation. Avance is a peripheral nerve scaffold approved for sensory . Read more

October 24th, 2025

Las Vegas, NV  / CRWE PRESS RELEASE / October 24, 2025 — FOR IMMEDIATE RELEASE — Bondezz™, today announced the appointment of Brian Colando as Vice President of Sales. In this role, Brian Colando will oversee the development of. Read more

October 18th, 2023

Shares of Sage Therapeutics, Inc. (Nasdaq: SAGE), a leading biopharmaceutical company specializing in neurological and neuropsychiatric disorders, surged over 5% in pre-market trading after the company said that the U.S. Food and Drug Administration . Read more

October 02nd, 2023

Shares of Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) surged by more than 20% in pre-market trading following the company's decision to discontinue its Phase 2b clinical trial of ibezapolstat, its lead antibiotic candidate, designed for the treatment . Read more

September 26th, 2023

Shares of Profound Medical Corp. (Nasdaq: PROF) surged by more than 10% in after-hours trading after it announced FDA clearance for its Thermal Boost module in conjunction with TULSA-PRO, which allows surgeons to treat various prostate conditions, in. Read more

September 25th, 2023

Shares of Femasys Inc. (Nasdaq: FEMY) surged by over 100% in after-hours trading following the company's announcement of receiving 510(k) Clearance from the United States Food and Drug Administration (FDA) for its groundbreaking infertility treatment. Read more

September 20th, 2023

Shares of ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) plunged over 40% following the announcement that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for neffy (epinephrine na. Read more

September 15th, 2023

Shares of Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) surged over 10% after the U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) for lifileucel due to resource constraints. The new target action date is . Read more

September 13th, 2023

Semtech Corporation (Nasdaq: SMTC), a technology company specializing in semiconductor solutions, reported earnings of $0.11 per share for the second quarter of fiscal 2024, surpassing the consensus EPS estimate of $0.02. Quarterly sales for Semtech . Read more