FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Becton Dickinson Expands Alaris Pump Recall

[ Price : $8.95]

Becton Dickinson expands its Class 1 recall of its Alaris Pump Module model 8100 to include 15 additional infusion sets, citing po...

FDA DTC Push Cites GLP-1 Drugs in 4 Letters

[ Price : $8.95]

FDAs ongoing crack down on drug direct-to-consumer promotional activities results in three just-released Warning Letters to Eli Li...

Dexcom Recalls G7 and ONE + Apps

[ Price : $8.95]

Dexcom recalls (Class 1 device correction) its Dexcom G7 App and Dexcom ONE+ App which contain a software design error.

aTyr Pharma Reports Mixed Results in Lung Trial

[ Price : $8.95]

aTyr Pharma reports mixed topline results from its Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis, a chronic infla...

Breakthrough Status for Gynecologic Cancer Therapy

[ Price : $8.95]

FDA grants Merck and Daiichi Sankyo a breakthrough therapy designation for raludotatug deruxtecan and its use for treating patient...

Tandem Recalls t:slim Insulin Pumps

[ Price : $8.95]

Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps after identifying a potential speaker-rel...

FDA OKs Corstasis Therapeutics Edema Nasal Spray

[ Price : $8.95]

FDA approves a Corstasis Therapeutics NDA for Enbumyst (bumetanide), a nasal spray loop diuretic for treating edema linked to cong...

FDA Cites Olympia Pharma Over GMPs

[ Price : $8.95]

FDA issues Olympia Pharmaceuticals a three-item Form FDA-483 following a 7/28-8/8 inspection of the firms Orlando, FL manufacturin...

Krystal Wins Expanded Label for Gene Therapy

[ Price : $8.95]

FDA approves a Krystal Biotech supplemental BLA for a label expansion on its gene therapy Vyjuvek (beremagene geperpavec-svdt), ad...

CBER Says AstraZeneca FluMist Ad Misled Viewers

[ Price : $8.95]

CBER sends an untitled letter to AstraZeneca citing the firm for running a misleading television direct-to-consumer advertisement ...