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FDA UPDATE: Paclitaxel-Coated Balloons, Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality americanpharmaceuticalreview
August 09, 2019
Earlier this year, the U.S. Food and Drug Administration (FDA) notified health care providers about a late mortality signal in patients treated for peripheral artery disease (PAD) in the femoropopliteal artery with paclitaxel-coated balloons and ......
Warnings Issued to Companies Illegally Selling E-Liquid, Hookah Products drugs
August 09, 2019
Warning letters about 44 flavored e-liquid and hookah tobacco products being sold illegally in the United States have been sent to four companies, the U.S. Food and Drug Administration says.
FDA Reports More Seizures Among Vapers drugs
August 09, 2019
There have been 118 more reports of electronic cigarette users suffering seizures since the U.S. Food and Drug Administration first warned the public about the danger in April.
Agenus, Gilead Milestone Triggers $7.5M Payment contractpharma
August 09, 2019
FDA acceptance of IND filing for AGEN237 represents the second milestone in Gilead partnership achieved in 2019.
FDA grants orphan drug designation to Stoke Therapeutics’ STK-001 pharmaceutical-technology
August 08, 2019
The US Food and Drug Administration (FDA) has granted orphan drug designation to Stoke Therapeutics’ antisense oligonucleotide, STK-001, a new therapy for severe and progressive genetic epilepsy Dravet syndrome.
Novartis defends Zolgensma in face of FDA’s data concerns pharmaceutical-technology
August 08, 2019
The US Food and Drug Administration (FDA) has issued a statement regarding data accuracy issues related with Novartis’ biologic license application (BLA) for gene therapy Zolgensma (onasemnogene abeparvovec-xioi).
FDA Approves Therapy for Symptomatic Tenosynovial Giant Cell Tumor americanpharmaceuticalreview
August 08, 2019
The U.S. Food and Drug Administration (FDA) has granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with ...
FDA Approval of Zolgensma Was Based on Manipulated Data drugs
August 08, 2019
The maker of Zolgensma (onasemnogene abeparvovec-xioi) gave manipulated data to the U.S. Food and Drug Administration when it approved the drug, the agency said Tuesday.
Carbogen Amcis API Site Passes FDA PAI contractpharma
August 08, 2019
Completes successful FDA inspection of its Neuland site in Hunzenschwil, Switzerland with no Form 483s.
Gilead's Descovy seems set for a PrEP nod in men, FDA review shows. But what about women? fiercepharma
August 07, 2019
As FDA panel experts gear up to debate the merits of Gilead’s Descovy for HIV prevention, the question doesn’t seem to be whether it’s worthy of an indication in men, the largest part of the market. It’s whether it should get a green light in women.

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