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May 11, 2020

Background Information: List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book)

Why are there two Purple Books? The “Purple Book” began as two lists (one for the CDER and one for CBER) that kept track of each […]
May 11, 2020

FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers

On May 8, 2020, the Food and Drug Administration expanded the indication of olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) to include its combination with bevacizumab for first-line […]
May 11, 2020

Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research [Updated 5/11/2020] FDA plays a critical role in protecting the United States […]
May 11, 2020

Plum Dragon Herbs, Inc. – 05/08/2020

Product: Drugs Recipient: Recipient Name Lisa Ball Plum Dragon Herbs, Inc. 102 Chester VillageChester, MD 21619United States [email protected] Issuing Office: Center for Drug Evaluation and Research […]
May 11, 2020

Seanjari Preeti Womb Healing, L.L.C. – 607355 – 05/08/2020

Product: Drugs Recipient: Recipient Name Ivy Ruffin (Sagarius) Seanjari Preeti Womb Healing, L.L.C. 1000 North Pine StreetSpartanburg, SC 29303United States [email protected] Date:          May 8, 2020 […]
May 11, 2020

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

On May 8, 2020, the Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMO, Eli Lilly and Company) for the following indications: Adult patients with […]
May 8, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 8, 2020

For Immediate Release: May 08, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
May 8, 2020

FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion

For Immediate Release: May 08, 2020 Today, the U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell […]
May 8, 2020

ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer’s Injection, USP Due to the Presence of Particulate Matter

Summary Company Announcement Date: May 08, 2020 FDA Publish Date: May 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulates (iron […]
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