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Calcimar Not Withdraw Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Sanofi Aventis Calcimar (calcitonin salmon) injection, 200 IU/mL was not withdrawn fr...

Aegea Vapor System Regulatory Review Period

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Tsunami MedTechs Aegea Vapo...

Suggestions for Use Instructions Guidance

[ Price : $8.95]

Four stakeholders suggest changes to an FDA draft guidance on the format and content of instructions for use information for drugs...

Comments Sought on 21 Substances for Drug Scheduling

[ Price : $8.95]

Federal Register notice: FDA requests comments on 21 drug substances concerning abuse potential, actual abuse, medical usefulness,...

Crysvita BLA to be Submitted

[ Price : $8.95]

Ultragenyx and Kyowa Kirin say they will submit an sBLA for a new indication for their Crysvita in the first half of 2020.

Courts Let Companies Keep Drug Risks Secret: Reuters

[ Price : $8.95]

A Reuters investigative report examines the way in which a federal court allowed Merck to keep some Propecia risk information secr...

Hospira Recalls 1 Lot of Bacteriostatic Water

[ Price : $8.95]

Hospira recalls one lot of its bacteriostatic water for injection, USP, 30 mL, multi-dose vial due to sterilization concerns.

FDA Aims to Ban Flavored e-Cigarettes

[ Price : $8.95]

FDA moves to ban non-tobacco-flavored e-cigarettes at the urging of President Trump during a 9/11 White House meeting with acting ...

Nerlynx sNDA for 3rd-line HER2 Breast Cancer

[ Price : $8.95]

FDA accepts for review a Puma Biotechnology supplemental NDA for Nerlynx (neratinib) in combination with capecitabine for treating...

Electrostimulation Device a 'Breakthrough': FDA

[ Price : $8.95]

FDA grants Checkpoint Surgical a breakthrough device designation for the companys brief electrostimulation therapy system for nerv...