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Sanofi Pays $12 Million to Settle False Claims

Sanofi-Aventis agrees to pay almost $12 million to resolve allegations that it violated the False Claims Act by paying kickbacks to Medicare patients ...

Human Drugs

Pfizer, Lilly BLA for Osteoarthritis Pain

FDA accepts for review a Pfizer and Eli Lilly BLA for tanezumab 2.5 mg administered subcutaneously for patients with chronic pain due to moderate-to-s...

Biologics

BLA for Multiple Myeloma Therapy Approved

FDA approves a Sanofi BLA for Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone for treating adults with relapsed refracto...

Human Drugs

Sandoz $195 Million Fine in Price Fixing Scheme

Sandoz agrees to pay a $195 million criminal penalty under a deferred prosecution agreement in an ongoing generic drug price-fixing investigation.

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 2/28/2020.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

FDA Reports Coronavirus-caused Drug Shortage

FDA says an unidentified drug manufacturer has alerted the agency about a drug shortage related to a manufacturing site affected by the coronavirus.

Human Drugs

Generics Group Opposes Changes to 180-day Exclusivity

The Association for Accessible Medications steps up pressure on Congress to reject legislation to change FDAs 180-day marketing exclusivity awards for...

Human Drugs

FDA OKs Esperions Combo Cholesterol Drug

FDA approves an Esperion NDA for Nexlizet (bempedoic acid and ezetimibe) as an adjunct to diet and maximally tolerated statin therapy for treating cer...

Human Drugs

Pilot on Drug Guidance Snapshots

FDA launches a new pilot program to simplify public awareness about guidance documents that seek to modernize drug clinical trials and accelerate drug...