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Allecra Therapeutics Announces Positive Top-Line Results for Phase 3 ALLIUM Clinical Trial of EXBLIFEP® for Complicated Urinary Tract Infections

SAINT-LOUIS, France and WEIL AM RHEIN, Germany, Feb. 25 (Korea Bizwire) — Allecra Therapeutics today announced that its investigational product EXBLIFEP (cefepime-enmetazobactam) met the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) pre-specified primary endpoint in the Phase 3 ALLIUM clinical trial in patients with complicated urinary tract infections (cUTI), including acute [...]

CoImmune, Inc. Announces FDA Approval of its IND Application to Conduct a Phase 2b Clinical Trial with CMN-001 in Advanced RCC Patients

DURHAM, N.C., Feb. 19 (Korea Bizwire) — CoImmune, Inc. announced today that the FDA approved its investigational new drug application (IND) and that it is cleared to move forward with a Phase 2b clinical trial in advanced metastatic renal cell carcinoma (mRCC). CMN-001, formerly known as AGS-003, is a dendritic cell-based immunotherapy custom matched to [...]

RedHill Biopharma Announces FDA Approval of Talicia® for Treatment of H. pylori in Adults

TEL-AVIV, Israel and RALEIGH, N.C., Nov. 4 (Korea Bizwire) – RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of proprietary drugs for the treatment of gastrointestinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Talicia® (omeprazole magnesium, amoxicillin and [...]

SunGen Pharma Receives Eighth ANDA Approval from US FDA

PRINCETON, N.J., Oct. 31 (Korea Bizwire) — SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its eighth ANDA approval from the US Food and Drug Administration (FDA). The eighth approved ANDA is for Lidocaine Ointment USP, 5%, Package size: 1 ½ [...]

SunGen Pharma Receives Seventh ANDA Approval from US FDA

PRINCETON, N.J., Sept. 5 (Korea Bizwire) — SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its seventh ANDA approval from the US Food and Drug Administration (FDA). The seventh approved ANDA is for Fosapreptant for Injection 150mg/vial. This drug product is [...]

SunGen Pharma Receives Sixth ANDA Approval from US FDA

PRINCETON, N.J., Jul. 8 (Korea Bizwire) — SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its sixth ANDA approval from the US Food and Drug Administration (FDA). The sixth approved ANDA is for Methylprednisolone tablets, 4 mg. This drug product is [...]

TeraRecon Receives First-of-Kind FDA Determination

DURHAM, N.C., Jun. 20 (Korea Bizwire) — Advanced visualization and artificial intelligence (AI) technology provider, TeraRecon, today announced it has successfully completed an FDA regulatory review of its Northstar™ AI Results Explorer, for which the technology and the determination are both firsts-of-kind in the medical imaging industry. Northstar is designed to work alongside the company’s EnvoyAI™ interoperability [...]

Nanobiotix Announces its Clinical Registration Plan in Head and Neck Cancers for the United States Following FDA Feedback

Paris, France; Cambridge, Massachusetts (USA); Mar. 26 (Korea Bizwire) – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205 – the ‘‘Company’’), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced that the Company has clarity on its regulatory pathway in the treatment of Head and Neck cancers for first-in-class radioenhancer NBTXR3. The [...]

SK’s New Sleep Disorder Drug Wins FDA Approval

SEOUL, Mar. 21 (Korea Bizwire) — A biopharmaceutical affiliate of South Korea’s SK Group said Thursday that it has won sales approval from the U.S. Food and Drug Administration (FDA) for its sleep disorder drug. The product, named Solriamfetol, is the country’s first indigenous drug for the central nervous system to receive the greenlight from [...]

NSF International to Provide Third-Party Certification of U.S. FDA Food Safety Requirements

ANN ARBOR, Mich., Feb. 25 (Korea Bizwire) — NSF Certification, LLC, a wholly-owned subsidiary of global public health organization NSF International, is now accredited by the American National Standards Institute (ANSI) to certify supplier compliance to U.S. food safety regulations under the FDA’s Accredited Third-Party Certification program. Certification under NSF’s newly accredited import supplier certification [...]