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April 26, 2021

FDA-Arthritis Foundation Osteoarthritis Drug Development Workshop: Assessment of Long-term Benefit – 06/22/2021 – 06/22/2021

On This Page Date: June 22, 2021 Time: 10:00 AM – 5:00 PM ET Date:                                       June 22, 2021Time:                                      10:00-5:00 p.m. ETLocation:  […]
April 26, 2021

Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics VI (GREAT VI) Workshop on Eosinophilic Gastrointestinal Disorders Beyond EoE – 07/21/2021 – 07/21/2021

On This Page Date: July 21, 2021 Time: 10:00 AM – 3:30 PM ET Workshop Summary The goal of the GREAT VI workshop is to discuss […]
April 26, 2021

Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators

Docket Number: FDA-2021-D-0320 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to describe the nonclinical information that […]
April 23, 2021

FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma

On April 23, 2021, the Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, […]
April 22, 2021

FDA grants accelerated approval to dostarlimab-gxly for dMMR endometrial cancer

On April 22, 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent […]
April 22, 2021

FDA Stresses Critical Importance of Safe Disposal of Medications Ahead of National Prescription Drug Take Back Day

Image By: Douglas C. Throckmorton, M.D., Deputy Center Director for Regulatory Programs, Center for Drug Evaluation and Research Unused or expired medicines in the home have […]
April 21, 2021

Lo que debe saber sobre el cáncer colorrectal

Image English El año pasado, en los Estados Unidos, se diagnosticó a más de 136,000 personas con cáncer colorrectal, y más de 50,000 murieron a causa […]
April 20, 2021

BD Announces the Voluntary Recall of Specified Lots of ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator in the United States and U.S. Territories Due to Defective Applicator

Summary Company Announcement Date: April 20, 2021 FDA Publish Date: April 20, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Defective applicator Company Name: […]
April 20, 2021

Hou Fu Biotech – 611644 – Jiangsu Co., Ltd

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Zhi Guo Wu Recipient Title CEO Hou Fu Biotech – Jiangsu Co., Ltd Building 5 South […]
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