Thursday, January 23, 2025

Yearly Archives: 2019

Aquestive Therapeutic’s Libervan (diazepam) Buccal Film Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for the Management...

Dec. 02, 2019:  Aquestive Therapeutics, Inc. announced the completion, as planned, of the rolling submission of a New Drug Application (NDA) to the U.S. Food and...

FDA approved Innovent Biologic’s Acceptance of NDA submission for Pemigatinib(FGFR1/2/3 inhibitor) in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with...

Dec 02, 2019:  Innovent Biologics, Inc. announced that Incyte submit the new drug application (NDA)  to the U.S. Food and Drug Administration (FDA) for pemigatinib in...

The European Commission approved Celltrion’s Remsima SC (infliximab) trials for the treatment of Chron’s disease, ulcerative colitis and rheumatoid arthritis

Nov 29, 2019: Evaluating a subcutaneous (SC) biosimilar version of the treatment in patients with Chron’s disease, ulcerative colitis and rheumatoid arthritis, Celltrion has...

EOS imaging receives U.S. FDA 510(k) clearance for EoSedge™ its new generation innovative imaging system , EoSedge in Europe, Canada and Australia

Nov 29, 2019 – EOS imaging announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new...

Y-mAbs Initiates Submission of Biologics License Application to U.S. FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma

Nov. 29, 2019 : Y-mAbs Therapeutics, Inc., announced that it is the submitted to the U.S. Food and Drug Administration (“FDA”) the first portions...

US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for AstraZeneca’s Imfinzi (durvalumab) for the...

Nov 29, 2019:US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for AstraZeneca’s Imfinzi (durvalumab) for the treatment of...

Collaboration of Bayer and Pharmaron to develop new molecular entities for veterinary medicines

Nov 28, 2019:Bayer and Pharmaron jointly develop new molecular entities for veterinary medicines, this will include drug substance and drug product manufacturing to support...

QIAGEN and DiaSorin receive FDA approval for the LIAISON QuantiFERON-TB Plus Test the fourth-generation modern gold standard for latent tuberculosis (TB) detection, on DiaSorin’s...

Nov 27, 2019: QIAGEN and DiaSorin received FDA approval for the LIAISON QuantiFERON-TB Plus Test (QFT-Plus), the fourth-generation modern gold standard for latent tuberculosis...

NICE approves Ibrance via Cancer Drugs Fund in combination with fulvestrant for the treatment of women who have hormone receptor positive (HR+) and HER2-...

Nov 28, 2019: The National Institute for Health and Care Excellence (NICE) approves Pfizer’s Ibrance (palbociclib), through the Cancer Drugs Fund (CDF), for use in combination with...

Elsevier acquires 3D4Medical, initiator of world-leading 3D anatomy technology and design

Nov 27, 2019: Elsevier has acquired 3D4Medical, the global anatomy education company headquartered in Dublin, Ireland. This is the world’s most advanced 3D anatomy platform,...

USFDA Approves Biocon and Mylan’s supplemental Biologics License Application (sBLA) for Pegfilgrastim Drug Substance to be manufactured at Biocon’s new Biologics manufacturing facility

Nov. 27, 2019: U.S. Food and Drug Administration (FDA) approved Biocon and Mylan's supplemental Biologics License Application (sBLA) for Pegfilgrastim  Drug Substance to be...

The U.S. Food and Drug Administration orders Puerto Rico fertility clinic to stop manufacturing immediately for significant violations Due to significant violations of FDA...

Nov 27, 2019: Due to significant violations of FDA regulations, The U.S. Food and Drug Administration has ordered Gynecology, Reproductive Endocrinology and Fertility Institute of San...
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