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FDA De Novo for Owlet Dream Sock

[ Price : $8.95]

FDA grants Owlet a de novo marketing authorization for its Dream Sock, an over-the-counter medical pulse oximetry solution for inf...

Samsung Seeks Interchangeable Humira Biosimilar

[ Price : $8.95]

FDA accepts for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab...

Brochure Overstates Phexxi Benefits: OPDP

[ Price : $8.95]

An FDA untitled letter cautions Evofem Biosciences that a promotional brochure for its on-demand contraceptive Phexxi overstates t...

Takeda Gets Approval for Fruzaqla

[ Price : $8.95]

FDA approves a Takeda Pharmaceuticals NDA for Fruzaqla (fruquintinib) for use in certain adult patients suffering from metastatic ...

FDA Updates Keytruda Gastric Cancer Indication

[ Price : $8.95]

FDA revises the indication for Mercks Keytruda and approves a companion diagnostic test.

FDA Clears Covid Antigen Home Test

[ Price : $8.95]

FDA clears an ACON Laboratories 510(k) for its Flowflex Covid-19 Antigen Home Test, which was originally authorized for emergency ...

Blood Storage Container is Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies the container system for the processing and storage of red blood cell components under red...

Takedas Adzynma Approved by FDA

[ Price : $8.95]

FDA approves Takedas Adzynma, a recombinant protein product designed for prophylactic or on‑demand enzyme replacement therap...

Cyltezo Exclusivity End Dates Recommended

[ Price : $8.95]

The CDER Office of Therapeutic Biologics and Biosimilars recommends expiration dates for first interchangeable exclusivity for Boe...

Cogentin Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Akorns Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to...