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Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA

Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA

Ann Arbor, Mich., USA, April 2 (Korea Bizwire) — In early March 2020, Amarex Clinical Research LLC, an NSF International company, executed a rush submission of an emergency use Investigational New Drug (IND) application to add COVID-19 as a new indication for CytoDyn’s monoclonal antibody product, Leronlimab. The product is currently being tested for HIV [...]

Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab in Combination with Pfizer’s Axitinib for the Treatment of Mucosal Melanoma

Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab in Combination with Pfizer’s Axitinib for the Treatment of Mucosal Melanoma

SHANGHAI, China, March 30 (Korea Bizwire) — Junshi Biosciences (HKEX: 1877) today announced that the U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug Designation (ODD) for toripalimab in combination with Pfizer’s axitinib for the treatment of patients with mucosal melanoma. Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi. Toripalimab received its [...]

Algernon Announces Filing of U.S. FDA Pre-IND Meeting Request for Ifenprodil Coronavirus Trial, Expanded Access, and Emergency Use

Algernon Announces Filing of U.S. FDA Pre-IND Meeting Request for Ifenprodil Coronavirus Trial, Expanded Access, and Emergency Use

VANCOUVER, British Columbia, March 13 (Korea Bizwire) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce that is has filed its pre-IND (Investigational New Drug) meeting request with the U.S. FDA. This initiates formal communications with the U.S. FDA regarding development [...]

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

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

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

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

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

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

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

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 [...]