The U.S. FDA added hidradenitis suppurativa to the label for UCB SA’s Bimzelx (bimekizumab-bkzx), throwing renewed light on the indication, a chronic disease that causes painful, boil-like lumps that appear under the skin. Regulators cleared the humanized IL-17A and IL-17F antagonist for adults with moderate to severe HS, marking the drug’s fifth approval.
Sangamo Therapeutics Inc. has received IND clearance from the FDA for ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to idiopathic small fiber neuropathy (iSFN).
Daiichi Sankyo Co. Ltd. and Astrazeneca plc have submitted a new BLA to the U.S. FDA for accelerated approval for datopotamab deruxtecan for treating locally advanced or metastatic epidermal growth factor receptor-mutated non-small-cell lung cancer patients who have received prior systemic therapies.
The U.S. FDA issued a complete response letter Nov. 15 for Izervay’s (avacincaptad pegol intravitreal solution, ACP) supplemental NDA, which sought to include positive two-year data for the Astellas Pharma Inc. therapy, previously approved for use in a treatment for geographic atrophy secondary to age-related macular degeneration.
Syndax Pharmaceuticals Inc. won U.S. FDA approval – the company’s second this year – for menin inhibitor Revuforj (revumenib) with a black box warning for differentiation syndrome. “We’ve long expected that would be the case,” said CEO Michael Metzger. For “the last six years or so” the agency has had a “heightened awareness” of the problem, and he predicted all drugs in the class would bear similar cautionary language. But there’s also a warning about QT prolongation and a requirement for monitoring.
Smartcardia SA received U.S. FDA clearance for mobile outpatient cardiac telemetry for its seven-lead live ECG monitoring patch and cloud platform. With the approval, the solution can now be used for remote live monitoring of a patient’s ECG and immediately notify clinicians in cases of arrhythmias.
President-elect Donald Trump’s nomination of Robert F. Kennedy Jr. as U.S. Secretary of Health and Human Services (HHS) grabbed headlines globally, but the political jostling to come will determine whether Kennedy can secure the seat.
Makers of devices and diagnostics face a new set of policy questions following the 2024 U.S. general elections, but many of the impending changes at the executive branch seem directed more toward drugs and vaccines, seemingly leaving the device and diagnostics industries largely out of harm’s way.
PTC Therapeutics Inc.’s accelerated go-ahead from the U.S. FDA for Kebilidi (eladocagene exuparvovec-tneq), a recombinant adeno-associated virus serotype 2-based gene therapy to treat aromatic L-amino acid decarboxylase (AADC) deficiency, came with a priority review voucher (PRV) that the company intends to monetize.
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