FDA – pharmaceutical daily news

FDA warns about fraudulent COVID-19 test kits for home use

March 21, 2020March 21, 2020 Dino Mustafić 0 Comments Coronavirus, COVID-19, FDA

The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.

My Pharmaceutical North America

FDA kicks off pilot program for recognizing qualified accreditation bodies who would accredit testing laboratories

September 21, 2019September 21, 2019 Dino Mustafić 0 Comments FDA, US FDA

The U.S. Food and Drug Administration issued a draft guidance Friday outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, designed to promote consistency and predictability in the premarket review process for medical devices, encourage effective use of FDA resources, and enhance regulatory efficiency, while also enhancing confidence in medical device testing.

Approval news

Beximco buys eight ANDAs in US from Novartis’ Sandoz

February 20, 2019February 20, 2019 Dino Mustafić 0 Comments Beximco Pharmaceuticals, FDA, Novartis, Sandoz

Beximco Pharmaceuticals Limited will buy from Novartis’ Sandoz a portfolio of eight Abbreviated New Drug Applications (ANDAs) in the US

Approval news

FDA approves Teva’s Sabril generic version; says making generic drugs competitive is key part to reduce drug cost

January 17, 2019 Dino Mustafić 0 Comments FDA, Sabril, Scott Gottlieb, Teva, vigabatrin

Announcing the approval of Teva’s Sabril generic tablets, FDA Commissioner, Scott Gottlieb said that prioritizing the approval of generic drugs to compete with medicines that face little or no competition is the Agency’s key part of efforts to support access and reduce drug costs to patients.

Approval news

Novartis locks Breakthrough Therapy for crizanlizumab in US, for prevention of sickle pain crises

January 8, 2019January 9, 2019 Dino Mustafić 0 Comments crizanlizumab, FDA, Novartis, sickle cell disease (SCD)

Novartis has secured its crizanlizumab (SEG101) Breakthrough Therapy designation US Food and Drug Administration (FDA), for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD).

Approval news

MatriSys asks for meeting with FDA over anti-atopic dermatitis topical drug candidate

January 3, 2019 Dino Mustafić 0 Comments dermatitis, FDA, MatriSys

MatriSys Bioscience is waiting to meet with the US FDA to complete preparations for its company-sponsored Phase 2 trial of its anti-atopic dermatitis topical drug candidate, MSB-01, it said Wednesday.

Approval news

PledPharma seeks to cut costs for Aladote, expects orphan drug designation

December 24, 2018December 24, 2018 Dino Mustafić 0 Comments FDA, Orphan Drug, PledPharma

PledPharma has filed an application for an Orphan Drug Designation (ODD) to the US FDA for the its drug candidate which should reduce liver injury by paracetamol overdose, Aladote.

Approval news

FDA grants Fast Track designation in the US for Nordic Nanovector’s Follicular Lymphoma drug

June 12, 2018 Dino Mustafić 0 Comments FDA, Nordic Nanovector

The US Food & Drug Administration (FDA) has granted Fast Track designation to Nordic Nanovector’s Betalutin (177Lu-lilotomab satetraxetan) for the treatment of

Approval news

FDA accepts larotrectinib Bayer’s New Drug Application and grants priority review

May 29, 2018 Dino Mustafić 0 Comments Bayer, FDA, Loxo Oncology

The U.S. Food and Drug Administration (FDA) has accepted Bayer’s partner’s Loxo Oncology’s New Drug Application (NDA), and granted Priority

news

FDA OK’s AkaRx’s liver drug

May 25, 2018May 25, 2018 Dino Mustafić 0 Comments AkaRx, FDA, liver disease

The U.S. Food and Drug Administration has approved AkaRx’s Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with

← Previous