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Sandoz Prolia/Xgeva Biosimilar BLA Submitted

[ Price : $8.95]

FDA accepts for filing a Sandoz BLA for a biosimilar version of Amgens denosumab (Prolia and Xgeva), which includes all indication...

FDA Urges Reporting of Home Covid Test Results

[ Price : $8.95]

FDA revises its online guide on when and how often people should use an over-the-counter at-home Covid-19 test to encourage users ...

Takeda sBLA for Takhzyro Expanded Indication

[ Price : $8.95]

FDA approves a Takeda supplemental BLA for an expanded use of Takhzyro (lanadelumab-flyo) prophylaxis to prevent attacks of hered...

Determinations on 31 Drugs Available for ANDAs

[ Price : $8.95]

Federal Register notice: FDA determines that 31 drug products were not withdrawn from sale due to safety or effectiveness reasons.

Rapid-Acting Depression Drug Gets Priority Review

[ Price : $8.95]

FDA accepts for priority review a Biogen and Sage Therapeutics, NDA for zuranolone, a rapid-acting once daily oral drug for major ...

Group Seeks Clinical Decision Support Guide Rescission

[ Price : $8.95]

A citizen petition from the Clinical Decision Support (CDS) Coalition urges FDA to rescind its controversial 9/2022 final guidance...

Device Co. Pays $500K over False Claims: DoJ

[ Price : $8.95]

Medical device manufacturer Joint Active Systems (Effingham, IL) agrees to pay $500,000 under a Justice Department settlement over...

Trodelvy OKd for Pre-treated Metastatic Breast Cancer

[ Price : $8.95]

FDA approves a Gilead Sciences supplemental BLA for Trodelvy for treating certain adult patients breast cancer who have received e...

Senators Urge Danco Labs to Expand Mifepristones Use

[ Price : $8.95]

Senator Jeanne Shaheen (D-NH) leads a group of Senators in sending a letter to Danco Laboratories, a manufacturer of mifepristone,...

FDA Corrects Notice on ANDA Withdrawals

[ Price : $8.95]

Federal Register notice: FDA corrects an 11/21/2022 notice that announced the approval withdrawals of 10 ANDAs from multiple appli...