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FDA Adds 4 APIs to Compounding List

[ Price : $8.95]

Federal Register notice: FDA identifies four drug substances to be added to its list of bulk drug substances (active pharmaceutica...

BMS/Bluebird Resubmit BLA for Multiple Myeloma

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Bristol Myers Squibb and Bluebird Bio re-file their BLA for idecabtagene vicleucel, indicated for treating patients with heavily p...

Catalyst Loses NDA Lawsuit Against FDA

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Catalyst Pharmaceuticals loses against FDA in a lawsuit over the agency's approval of competitor Jacobus Pharmaceuticals Ruzurgi (...

Ethicon Breakthrough Status for Transbronchial Ablation

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FDA grants Ethicon a breakthrough device designation for its transbronchial microwave ablation technology using robotic-assisted b...

Guide on Unit-Dose Repackaged Drugs Expiry Dating

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Federal Register notice: FDA makes available a final guidance entitled Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage...

Merck Files 2 sBLAs for Keytruda in Breast Cancer

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FDA accepts from Merck two supplemental BLAs for Keytruda (pembrolizumab) and its use in triple-negative breast cancer.

Eton Pharma NDA for Liquid Epilepsy Drug

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Eton Pharmaceuticals files an NDA for zonisamide oral suspension for treating partial seizures in patients with epilepsy.

FDA Proposes 4 Additions to Outsourcing Bulk Drug List

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FDA seeks comment on a proposal to add four bulk drug substances to the bulk list for drug compounders.

Takeda Gains Breakthrough for Pevonedistat

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FDA grants Takeda Pharmaceutical a breakthrough therapy designation for its investigational drug pevonedistat for treating patient...

Draft Guide on Pregnancy, Lactation Drug Labeling

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Federal Register notice: FDA makes available a draft guidance entitled Pregnancy, Lactation, and Reproductive Potential: Labeling ...