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migraine-oct14.jpg The U.S. Food and Drug Administration or FDA approved Reyvow (lasmiditan) tablets of Eli Lilly and Co. as an oral medication for the acute treatment of migraine, with or without aura, in adults. However, Reyvow is not indicated for prevention of migraine. Reyvow is a new oral treatment that binds to 5-HT1F receptors with high affinity.

painfreelightexposure-oct09.jpg The U.S. Food and Drug Administration has approved Clinuvel Pharmaceuticals' treatment Scenesse for a rare genetic disorder that induces skin damage from exposure to light. The FDA said it approved the use of Scenesse (afamelanotide) to treat erythropoietic protoporphyria or EPP, a rare genetic disorder characterized by an extreme risk of severe burns or phototoxicity of the skin.

Novartis AG (NVS) said the U.S. FDA has approved Beovu (brolucizumab) injection for the treatment of wet age-related macular degeneration, a chronic, degenerative eye disease. The approval was based on findings from the Phase III HAWK and HARRIER clinical trials. Novartis said, with the approval of...

fdaapprovesdescovy-oct04.jpg The U.S. Food and Drug Administration approved Gilead Sciences' drug Descovy to reduce the risk of sexually acquired HIV infection in adults and adolescents who do not have HIV, but are exposed to risk. This is the second drug to be approved by the FDA to prevent HIV infection as part of its efforts to end the epidemic. However, Descovy yet indicated for certain groups, including use by women.

Merck (MRK) announced the U.S. FDA has accepted for review a New Drug Application for DIFICID (fidaxomicin) for oral suspension, and a supplemental NDA, or sNDA, for a new indication for use of DIFICID tablets and oral suspension for the treatment of Clostridium difficile infections in children aged...

rituxan-sept30.jpg Vasculitis, which refers to inflammation of the blood vessels, is an autoimmune disease wherein the immune system attacks the body's own cells for unknown reasons. There are approximately 20 different disorders that are classified as "vasculitis". (Source: Johns Hopkins Vasculitis Center).

Swiss drug major Roche Group (RHHBY) announced Monday that the U.S. Food and Drug Administration has approved Rituxan (rituximab), in combination with glucocorticoids, to treat children with two rare blood vessel disorders. The approval is for the treatment of granulomatosis with polyangiitis or GPA...

AbbVie (ABBV) said that the U.S. Food and Drug Administration has approved MAVYRET or glecaprevir/pibrentasvir to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C or HCV patients across all genotypes or GT1-6. In August 2017,...

Abbott Laboratories (ABT) said Thursday that the U.S. Food and Drug Administration has approved the company's Proclaim XR, recharge-free neurostimulation system for people living with chronic pain. The Proclaim XR platform offers a low dose of Abbott's proprietary BurstDR stimulation waveform. It...

abbott-bloodtest-092519.jpg Abbott Laboratories (ABT) said Wednesday that the U.S. Food and Drug Administration approved its Architect Stat High Sensitivity Troponin-I blood test that could help detect heart attacks faster and more accurately than the standard troponin tests.

monkeypox-sept25.jpg The U.S. Food and Drug Administration announced the approval of first live, non-replicating vaccine to prevent smallpox and monkeypox. The approval makes Bavarian Nordic A/S' Jynneos as the only FDA- approved vaccine available now to prevent monkeypox disease. The vaccine will be available for adults of 18 years of age and above determined to be at high risk for smallpox or monkeypox infection.

Biopharmaceutical company Bristol-Myers Squibb Co. (BMY) announced Tuesday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) flat dosing schedule of 240 mg infused over 30 minutes every two weeks (Q2W)...

British drug maker AstraZeneca Plc (AZN.L, AZN) announced Monday that Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets have been recommended for marketing authorisation in the European Union to treat adults with type-2 diabetes or T2D. The company noted that...

Merck (MRK), known as MSD outside the U.S. and Canada, announced Friday that the U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications (sNDAs) for PIFELTRO (in combination with other antiretroviral agents) and DELSTRIGO (as a complete regimen) that expand their indications...

Roche (RHHBY) has received FDA approval for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing. Cobas Babesia detects parasites that live in red blood cells. Roche said the whole blood test to screen donations follows May 2019 FDA-updated industry guidance...

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