December 1, 2022

Ongoing | Non-malignant Hematology, Neurological Disorders, and Other Indications Accelerated Approvals

Skysona (elivaldogene autotemcel) Indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (cald) 9/16/2022 PMR 1: […]
December 1, 2022

Accelerated Approval Program

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on […]
November 30, 2022

FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

[11/30/2022] The U.S. Food and Drug Administration today announced bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize […]
November 29, 2022

Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage UPDATED November 28, 2022

Summary Company Announcement Date: November 28, 2022 FDA Publish Date: November 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: […]
November 29, 2022

Shuzy Rock Inc. – 630110 – 09/01/2022

Delivery Method: VIA EMAIL AND UNITED PARCEL SERVICE Product: Drugs Recipient: Recipient Name Mr. Aharon Stefansky and Mr. Shulem Iskowitz Recipient Title Co-Owners Shuzy Rock Inc. […]
November 29, 2022

“David M. Lubeck, M.D./Arbor Centers for EyeCare – 643531 – 11/18/2022

Delivery Method: VIA UNITED PARCEL SERVICE Product: Drugs Recipient: Recipient Name David M. Lubeck, M.D. “David M. Lubeck, M.D./Arbor Centers for EyeCare 9731 West 165th Street, […]
November 28, 2022

Zydus Lifesciences Limited – 584856 – 11/03/2022

Reference #: 3002984011 Product: Drugs Recipient: Recipient Name Dr. Shavril Patel Recipient Title Managing Director Zydus Lifesciences Limited Cadila Healthcare Limited Khoraj (Gandhinagar)Nr. Vaishmodevi CircleAhmedabad 382481GujaratIndia […]
November 28, 2022

Cadila Healthcare Limited – 584856 – 10/29/2019

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Pankaj R. Patel Recipient Title Chairman Cadila Healthcare Limited Zydus Tower, Satellite Cross RoadsAhmedabad 380015GujaratIndia Issuing […]
November 25, 2022

Guidance Webinar Series

FDA’s Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders. The first-in-a-series of Guidance Webinars […]
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