Regulatory

Dovato is the first oral, two-drug, single-tablet regimen approved for patients 12 years of age and older who are living with HIV-1.

According to the letter, the FDA believes that the investigational apomorphine infusion device is not ready for approval in its current form.

The approval of AstraZeneca’s and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive solid tumors adds to the drug's approved indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma.

Decision to discontinue marketing authorizations for Relyvrio/Albrioza comes as a result of topline results from the Phase III PHOENIX trial in patients with amyotrophic lateral sclerosis.

Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who were previously administered two or more lines of therapy.

Fanapt was previously approved by the FDA in 2009 as an antipsychotic treatment for schizophrenia.

Approval comes amid positive results from TRILUMINATE trial, which demonstrated improvement in 90% of participants treated for a leaky tricuspid heart valve.

The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says.

Approval would mark first HER2-targeted therapy for biliary tract cancer in the United States.

Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis.

Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy.

Approval of Vafsen (vadadustat) based on promising results from the INNO2VATE program and additional safety data from use in Japan in adults with chronic kidney disease.

Evolut FX+ transcatheter aortic valve replacement system design includes a larger coronary access window through a modified frame.

Action marks the first FDA-approved blood screening test for malaria.

Winrevair is the first FDA-approved activin signaling inhibitor therapy for pulmonary arterial hypertension.

Alexander continues her conversation, touching on topics like disinformation and diversity in clinical trials.

Alexander discusses the broader implications the case could have on FDA's ability to regulate the industry.

Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are positive for the anti-aquaporin-4 antibody.

The FDA granted accelerated approval to Elahere in November 2022 for patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who were previously administered one to three systemic treatment regimens.

In clinical trials, the newly approved Opsynvi led to a greater drop in pulmonary vascular resistance after 16 weeks compared with both tadalafil and macitentan monotherapy.

Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of age and older with Duchenne muscular dystrophy.

Valder Curran discusses recent developments with the IRA.

MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy.

Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies.

Expanded indication for Edurant in combination with other antiretroviral therapies includes treatment-naïve children with HIV-1 RNA <100,000 copies/mL aged at least 2 years and weighing between 14 kg and 25 kg.

Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

Indication of Spevigo (spesolimab-sbzo) expanded for the treatment of generalized pustular psoriasis in patients 12 years of age and older weighing ≥40 kg.

In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment.

Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors.

CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) approved for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered at least two lines of therapy.