FDA
A more detailed review of data by the FDA showed that GLP-1 drugs do not increase the risk of suicidal ideation or behavior.
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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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Despite the approval, Samsung Bioepis’ Hadlima will not be available in the U.S. until 2023, due to licensing deals with AbbVie, the maker of Humira.
For LENVIMA plus KEYTRUDA Combination Treatment as Potential First-Line Treatment of Patients with Advanced Unresectable Hepatocellular Carcinoma Not Amenable to Locoregional Treatment
Myxredlin is intended for use only in acute care settings under medical supervision.
The drug is approved for use for management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for partial-onset seizures in patients 17 years of age and older, fibromyalgia, and neuropathic pain associated with spinal cord injury.
The FDA approval marks the first for oral ulcers associated with Behçet’s Disease and the third for Otezla.
Phase 1/2 trial to be HOOKIPA’s first clinical trial in immuno-oncology
The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to AstraZeneca over its supplemental New Drug Application (sNDA) for Farxiga (dapagliflozin) as an adjunct treatment to insulin for type 1 diabetes (T1D) when insulin alone doesn’t keep blood sugar levels under control.
The FDA approval marks the first drug approved for Azurity, a company formed from the merger of CutistPharma and Silvergate.
SonoCloud ultrasound device for glioblastoma patients will be tested for first time at US clinical sites
Da Volterra, a clinical-stage biopharmaceutical company developing new therapeutics to protect the intestinal microbiota, announced the completion of patient recruitment for its Phase 2 trial ‘SHIELD’ evaluating DAV132 in patients receiving antibiotics.