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FDA Releases Coronavirus Supply Chain Update contractpharma
March 03, 2020
Manufacturer alerts FDA to a shortage of a drug related to site affected by coronavirus.
Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel FDA
March 03, 2020
Today, in a joint effort, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel.
Drug Trials Snapshots prnasia
March 02, 2020
Drug Trials Snapshots provide consumers and healthcare professionals with concise information about who participated in clinical trials that supported the FDA approval of new drugs.
Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics FDA
March 02, 2020
FDA issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.
Tessa Therapeutics Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to its CD30 CAR-T Cell Therapy for the Treatment of Relapsed or Refractory CD30-positive Classical Hodgkin Lymphoma prnasia
February 29, 2020
Tessa expects to initiate its pivotal Phase II multi-site trial in the fourth quarter of 2020.
U.S. FDA accepts GSK's sNDA application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer prnasia
February 25, 2020
GlaxoSmithKline plc today announced that the U.S. Food and Drug Administration (FDA) accepted the company's submission of a supplemental New Drug Application (sNDA) seeking approval of Zejula (niraparib) as a maintenance treatment in the first-line settin
Numbers of Drug Approval by FDA, EMA and NMPA in 2019 En-CPhI.Cn
January 23, 2020
A quick review of drug approval in the past 2019 by NMPA, EMA and FDA.
ANI Announces FDA Approval of Potassium Citrate Extended-Release Tablets americanpharmaceuticalreview
January 19, 2020
ANI Pharmaceuticals has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Potassium Citrate Extended-Release Tablets USP, 10 mEq and 15 mEq.
FDA Statement on Cardinal Health Surgical Gowns, Packs Quality americanpharmaceuticalreview
January 19, 2020
On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contain these gowns.
FDA Approves New Indication for Ozempic, Updated Rybelsus Prescribing Information americanpharmaceuticalreview
January 19, 2020
Novo Nordisk announced the U.S. Food and Drug Administration (FDA) has approved a new indication for Ozempic® (semaglutide) injection 0.5 mg or 1 mg to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke ...

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