FDA Related News

Human Drugs

Amylyx Pharmaceuticals NDA for ALS Drug

Amylyx Pharmaceuticals files an NDA for AMX0035 (sodium phenylbutyrate and taurursodiol), indicated for treating amyotrophic lateral sclerosis.

Human Drugs

FDA Accepts NDA for Parsaclisib in Lymphomas

FDA accepts for review an Incyte NDA seeking approval of parsaclisib for treating patients with relapsed or refractory follicular lymphoma, marginal z...

Human Drugs

ANI Pharma sNDA for Purified Cortrophin Gel

FDA approves an ANI Pharmaceuticals supplemental NDA for purified cortrophin gel (repository corticotropin) for treating certain chronic autoimmune di...

Biologics

Moderna Delaying Pediatric Covid Vaccine EUA Filing

Moderna says ongoing FDA safety concerns with Modernas Covid-19 vaccine and its potential use in adolescents has led to a filing delay for an emergenc...

Federal Register

Draft Guide on Drug Reporting to FDA

Federal Register notice: FDA posts a draft guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the F...

Federal Register

Drug Name Study on Consumer/Doc Interpretations

Federal Register notice: FDA seeks public comments on a proposed information collection entitled Text Analysis of Proprietary Drug Name Interpretation...

Medical Devices

Heart-assist Devices Recalled Due to Battery Risk

Datascope/Getinge/Maquet recalls its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs due to a battery failure risk.

Ex-Sales Rep Sentenced to 4 Years Over Fraud

An Illinois federal judge sentences a former Aegerion Pharmaceuticals sales rep to 54 months in prison for using the identities of physicians to carry...

Human Drugs

J&J Settles Risperdal Liability Cases for $800 Million

Johnson & Johnson takes a $800 million hit to settle substantially all outstanding cases against its Risperdal drug product over personal injury claim...

Human Drugs

New Clozapine REMS Requires Recertification by 11/15

FDA says that beginning 11/15 new requirements under the FDA-approved Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program require all pat...