fbpx
April 9, 2021

NS NY Distributor Inc Issues Voluntary Nationwide Recall of Premium OrgaZen 7000 and Ginseng Power 5000 Due to Presence of Undeclared Sildenafil and/or Tadalafil

Summary Company Announcement Date: April 08, 2021 FDA Publish Date: April 09, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and/or Tadalafil […]
April 9, 2021

DDT COA #000116: PROMIS Itch Questionnaire – Children Impact (PIQ-C-Impact)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Dermatology and Dentistry (DDD) DDT COA NumberDDT COA #000116 Instrument NamePROMIS Itch Questionnaire – […]
April 9, 2021

DDT COA #000140: PROMIS Itch Questionnaire – Children Symptom (PIQ-C-Symptom)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Dermatology and Dentistry (DDD) DDT COA NumberDDT COA #000140 Instrument NamePROMIS Itch Questionnaire – […]
April 9, 2021

FDA D.I.S.C.O. Burst Edition: FDA approval of ABECMA (idecabtagene vicleucel) the first FDA approved cell-based gene therapy for the treatment of adult patients with relapsed or refractory multiple myeloma

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
April 9, 2021

FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
April 9, 2021

Remarks by Dr. Janet Woodcock to the 2021 Rx Drug Abuse and Heroin Summit – 04/08/2021

Remarks by Dr. Janet Woodcock Acting Commissioner of Food and Drugs April 8, 2021 (Remarks as prepared for delivery) Thank you.  It is an honor to […]
April 9, 2021

FDA D.I.S.C.O. Burst Edition: FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies

Podcast Welcome back to the DISCO, FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
April 9, 2021

FDA D.I.S.C.O. Burst: Approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four lines of prior therapy

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
April 9, 2021

FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression with no eGFR, anaplastic lymphoma kinase or receptor tyrosine kinase aberrations

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0