FDA
Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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It’s a busy week for the U.S. Food and Drug Administration (FDA) with quite a number of pending drug approvals, several of which were delayed for a variety of reasons. Here’s a look.
The U.S. Food and Drug Administration (FDA) approved Aerie Pharmaceuticals Rocklatan (netarsudil and latanoprost ophthalmic solution) to decrease elevated intraocular pressure (IOP) in open-angle glaucoma or ocular hypertension.
Medical device company receives second FDA clearance, adding blood flow monitoring technology to portfolio
The U.S. Food and Drug Administration has been busy approving new treatments for various diseases. Two days into the new week and the regulatory agency has green lit two therapeutics, while other companies are planning to file for potential approval.
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells. It blocks interactions with both PD-1 and B7.1 receptors.
The next couple of weeks look to be busy for the FDA, with a string of target action dates scheduled. This week marks three scheduled approvals, two for extra indications for already-approved biologics, and the third for a combination treatment for glaucoma. Here’s a look.
Janssen believes the treatment works by restoring synaptic connections in brain cells in individuals with major depressive disorder.
Evaluate recently published the Vantage Pharma, Biotech and Medtech 2018 in review report. The annual report offers insights into the previous year’s activities in biopharma and the medical device industry.
MorphoSys AG announced that its licensee Janssen Research & Development, LLC, has reported that the U.S. Food and Drug Administration has approved Tremfya One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis.
FDA Approval Allows Interventional Cardiologists Access to Resolute DES Technology to Treat De Novo CTO