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FDA/Panel Decisions

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Gilead Sciences Inc. (GILD) said that the U.S. Food and Drug Administration has granted full approval to Trodelvy or sacituzumab govitecan-hziy for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer or TNBC who have received two or more prior systemic therapies,...

symbiotica april07 The U.S. Food and Drug Administration issued an emergency use authorization or EUA for the COVID-19 Self-Collected Antibody Test System developed by Symbiotica, Inc. It is the first antibody test authorized for use with home collected dried blood spot samples. The collected samples will be sent to a Symbiotica laboratory for analysis.

Biotechnology company Exelixis, Inc. (EXEL) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid...

Supernus Pharmaceuticals Inc. (SUPN) said that the U.S. Food and Drug Administration approved Qelbree or viloxazine extended-release capsules for the treatment of attention-deficit hyperactivity disorder or ADHD in pediatric patients 6 to 17 years of age. Supernus plans to make Qelbree available...

United Therapeutics Corporation (UTHR) announced that FDA has approved Tyvaso Inhalation Solution for the treatment of patients with pulmonary hypertension associated with interstitial lung disease to improve exercise ability. This is the second FDA-approved indication for Tyvaso. It was initially approved...

Denmark-based Genmab A/S (GMXAY.PK) announced Tuesday that the European Commission has granted Novartis (NVS) marketing authorization to use Kesimpta (ofatumumab) to treat relapsing forms of multiple sclerosis or RMS in adults with active disease defined by clinical or imaging features. Multiple sclerosis...

PTC Therapeutics Inc. (PTCT) said that the European Commission has approved Evrysdi or risdiplam for the treatment of spinal muscular atrophy in patients 2 months and older. Evrysdi will be for spinal muscular atrophy Type 1, Type 2 or Type 3 patients with one to four SMN2 copies. The EC approval...

genetherapy march29 Abecma has become the first cell-based gene therapy approved by the U.S. Food and Drug Administration for the treatment of multiple myeloma, an uncommon type of cancer. The FDA granted approval of Abecma to Celgene Corp., affiliated to Bristol Myers Squibb. Abecma is being jointly developed and commercialized in the U.S. as part of an agreement between Bristol Myers Squibb and bluebird bio Inc.

Qiagen N.V. (QGEN) announced Monday that the U.S. Food and Drug Administration or FDA has granted Emergency Use Authorization for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test. The polymerase chain reaction or PCR multiplex test will help healthcare professionals quickly identify and differentiate...

cannabidiol march23 Two companies have been warned by the U.S. Food and Drug Administration for illegally selling over-the counter pain relief products labeled as containing cannabidiol or CBD. In a statement, the health regulator said it issued warning letters to Honest Globe Inc. and Biolyte Laboratories LLC for selling the products listing CBD as inactive ingredient...

Vitro diagnostics company Ortho Clinical Diagnostics (OCDX) announced Tuesday that it received authorization from the U.S. Food and Drug Administration (FDA) to update key claims for the VITROS SARS-CoV-2 Antigen Test, the first high-volume SARS-CoV-2 antigen assay to receive Emergency Use Authorization...

Merck (MRK) said FDA has approved KEYTRUDA, the company's anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based...

Danish pharmaceutical company Novo Nordisk A/S (NVO) said Monday that the US Food and Drug Administration issued a Refusal to File letter covering the label expansion application for once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes which was filed on 20 January 2021. In the letter,...

biofire march19 The U.S. Food and Drug Administration or FDA granted the first marketing authorization for a SARS-CoV-2 diagnostic test using the De Novo review pathway, the traditional premarket review process. The test will now be permitted to be marketed beyond the public health emergency.BioFire Diagnostics LLC's BioFire Respiratory Panel 2.1 diagnostic test was granted the marketing authorization.

Baxter International Inc. (BAX) said Friday that it has received U.S. FDA 510(k) Clearance for its next-generation Artificial Kidney 98 dialysis machine. It is designed to be a portable and easy-to-use system to administer hemodialysis or HD treatments. Artificial Kidney 98 or AK 98 offers encrypted,...

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