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Theratechnologies’ Trogarzo for HIV, Alnylam’s Lumasiran for advanced primary hyperoxaluria, scPharmaceuticals’ Furoscix for heart failure and more. Here’s a look at the FDA’s October calendar.
Biopharma companies are expanding beyond the traditional confines of Massachusetts and California with hubs forming – most notably – in the South and Southeast.
The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
Shares of Rocket Pharmaceuticals jumped Friday morning after the company announced positive clinical updates from a Phase I study of patients diagnosed with Danon disease.
In its ongoing battle against counterfeit drug rings, Gilead Sciences announced it has identified two “kingpins” behind the scheme to sell illegitimate HIV medications.
The HHS Office of Inspector General found that of 278 accelerated approvals between 1992 and 2021, 104 had incomplete confirmatory trials, according to a report issued Thursday.
As it gears up to launch several new products, Moderna has created a new leadership role and onboarded an industry veteran.
This week had a flurry of biopharma patent cases, from Novartis vs Gilenya, Merck vs Viatris, and Aligos vs Janssen, either filed or court decisions being made.
Solid Biosciences and AavantiBio – announced Friday they are merging to develop a portfolio of neuromuscular and cardiac programs, initially focusing on Duchenne muscular dystrophy.
Two years after receiving a Complete Response Letter for its hemophilia gene therapy, BioMarin is heading back to the FDA with stronger and more robust data for potential approval.
Biogen and Eisai’s lecanemab win this week provides an opportunity to stop and consider whether science is closer to a cure or symptom management for Alzheimer’s disease.
The biopharma world - and markets - spent Thursday evening reacting after the FDA gave the green light to only its third-ever drug for ALS, Amylyx’s Relyvrio.
This week, researchers published results from studies on treatments in lung disease, Alzheimer’s and various cancers. Here’s a look at that and more.
Life science companies made adjustments to their leadership teams with multiple appointments for chief commercial officers, chief business officers and more in this week’s Movers & Shakers.
Biohaven Pharma’s verdiperstat, an experimental treatment for amyotrophic lateral sclerosis, failed to distinguish itself from placebo in clinical testing, the company announced Thursday.
Two rare disease companies - Idera Pharmaceuticals and Aceragen - are merging to pursue the common goal of an FDA approval that could come as early as 2024.
Eisai and Biogen announced positive data from a Phase III trial in Alzheimer’s of its drug lecanemab. Still, questions remain about the drug’s implications for the future of Alzheimer’s treatment.
Novo Nordisk struck a licensing deal Thursday with Ventus Therapeutics valued at up to $700 million to develop and commercialize peripherally-restricted NLRP3 inhibitors.
The FDA has approved Regeneron and Sanofi’s Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis, making it the first drug approved for this indication.
New data from Axcella, PepGen, Dystrogen and Galecto are showing promise in challenging diseases, including NASH, Duchenne muscular dystrophy and myelofibrosis.