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CytoDyn Inc. (CYDY) announced the FDA has provided clearance for initiation of a Phase 2 trial with leronlimab to treat COVID-19 patients with mild to moderate indications. The Phase 2 clinical trial is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab,...

fda march30 The U.S. Food and Drug Administration has issued an Emergency Use Authorization to allow anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate donated to the Strategic National Stockpile as possible treatments for coronavirus (COVID-19) patients. This is the first EUA for a drug related to the COVID-19 response.

Eli Lilly and Company (LLY) announced the U.S. FDA has approved a supplemental Biologics License Application for Taltz injection, 80 mg/mL for the treatment of pediatric patients (ages 6 to under 18) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz...

AstraZeneca plc (AZN.L, AZN) announced Monday that the U.S. Food and Drug Administration has approved Imfinzi (durvalumab) as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer or ES-SCLC. Separately, the company announced that Farxiga Phase III DAPA-CKD trial will be...

Sanofi (SNY, SNYNF) announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion for Sarclisa (isatuximab). The positive opinion is for the treatment of adult patients with relapsed and refractory multiple myeloma or RRMM. The...

Genentech, a member of the Roche Group (RHHBY), said FDA has accepted a New Drug Application as well as two supplemental New Drug Applications for Xofluza. Xofluza is FDA-approved to treat influenza in people 12 years of age and older. The New Drug Application for Xofluza is for the treatment of Influenza...

Pfizer Inc. (PFE) announced the U.S. FDA has approved the company's supplemental New Drug Application for EUCRISA ointment, 2%, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate atopic dermatitis. The company said the supplemental approval makes EUCRISA the...

Genentech, a member of the Roche Group (RHHBY.PK), said the U.S. FDA has approved a double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority to evaluate the safety and efficacy of intravenous Actemra plus standard of care...

Roche (RHHBY) said the U.S. FDA has issued an Emergency Use Authorization for the cobas SARS-CoV-2 Test for the qualitative detection of SARS-CoV-2, the novel coronavirus. Roche said Hospitals and reference laboratories can run the test on the company's fully automated cobas 6800 and cobas 8800 Systems....

Boehringer Ingelheim and Eli Lilly and Company (LLY) announced the FDA has granted Fast Track designation for the investigation of Jardiance (empagliflozin) to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease. Jardiance is a once-daily tablet...

Roche (RHHBY) said that the European Commission has approved Venclyxto or venetoclax in combination with Gazyvaro or obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia or CLL. Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly...

Roche (RHHBY) said the U.S. FDA has granted Breakthrough Device Designation to the Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma. The GALAD score is a serum biomarker-based model that predicts the probability of having hepatocellular carcinoma in patients with chronic liver...

Pfizer Inc. (PFE) and Eli Lilly and Company (LLY) announced the U.S. FDA accepted for review a Biologics License Application for tanezumab 2.5 mg administered subcutaneously, which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate...

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