FDA
The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agency’s 79 total approvals, including supplemental nods.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech 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.