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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 [...]

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

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 [...]

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

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 [...]

Update — US FDA Approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas Drug XOSPATA (gilteritinib fumarate) for Treatment of AML Patients in the US

Update — US FDA Approves Invivoscribe LeukoStrat CDx FLT3 Mutation Assay as CDx and Astellas Drug XOSPATA (gilteritinib fumarate) for Treatment of AML Patients in the US

SAN DIEGO, Nov. 29 (Korea Bizwire) — Invivoscribe is pleased to announce FDA approval of both the LeukoStrat CDx FLT3 Mutation Assay and the Astellas drug, XOSPATA (gilteritinib fumarate), for treatment of FLT3 positive refractory/relapse acute myeloid leukemia (AML) patients in the US.  Further, the Japanese MHLW has confirmed national reimbursement for the LeukoStrat CDx [...]

Neuralstem Announces NSI-189 Granted Orphan Drug Designation from the U.S. FDA for the Treatment of Angelman Syndrome

Neuralstem Announces NSI-189 Granted Orphan Drug Designation from the U.S. FDA for the Treatment of Angelman Syndrome

GERMANTOWN, Md., Aug. 9 (Korea Bizwire) — Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to NSI-189 for the treatment of Angelman syndrome. “Angelman Syndrome is a rare disease [...]

Celixir Announces US FDA Approval of the IND Application for Cell Therapy Heartcel

Celixir Announces US FDA Approval of the IND Application for Cell Therapy Heartcel

Stratford-upon-Avon, UK, Jun. 8 (Korea Bizwire) – Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for HeartcelTM, its immuno-modulatory progenitor (iMP) cell therapy for the treatment of adult heart failure. Celixir announced in January the approval [...]