Regulatory Authority Actions

Biocon Biologics’ Yesintek demonstrated comparable safety and efficacy to the originator project, according to clinical data from a trial program.

The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

If approved, zanidatamab would be the first HER2-targeted therapy licensed for biliary tract cancer in the EU.

Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.

The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.

Celltrion’s adalimumab-aaty is designated interchangeable as a high-concentration (100mg/mL) and citrate-free formulation of adalimumab.

Artificial intelligence will be a major component, FDA said, of the approaches the agency will be deploying to either reduce, refine, or potentially replace animal testing.

The EMA has issued a new proposal that aims to encourage biosimilar development and improve patient access to biosimilar therapies.

The commission’s approval makes durvalumab the first and only immunotherapy for LS-SCLC in the EU.

Omlyclo (omalizumab-igec) was approved to treat moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and certain food allergies.

Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.

FDA has accepted Sanofi’s sBLA for the mAb and granted it priority review status for the targeted treatment of bullous pemphigoid.

The approval provides greater access to insulin treatment options.

More than 6000 rare diseases—those which affect fewer than one in 2000 people each—are acknowledged in the medical community, with 72% of them being genetic.

Avtozma references Roche’s tocilizumab offering and has also shown promise as a treatment for CAR-T cell-induced cytokine release syndrome as well as COVID-19.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

Vimkunya was granted approval under priority review based on positive results from two Phase III trials.

Ospomyv, or Obodence in the EU, and Xbryk were approved for all indications referencing Prolia and Xgeva, respectively.

This expanded label allows IZERVAY (avacincaptad pegol intravitreal solution) to be used without a limitation on duration of dosing for treating geographic atrophy.

The vaccine combines the antigenic components of two previously well-established meningococcal vaccines made by GSK.

The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.

The approval makes Susvimo the first and only continuous delivery treatment for diabetic macular edema.

The committee’s recommendation was based on results from a Phase III trial that demonstrated a 27% reduction in the risk of death versus placebo.

Intravenous administration of amivantamab is the currently approved route, but a Phase III trial showed that subcutaneous treatment was non-inferior.

The UK MHRA has granted approval for garadacimab for use in preventing angioedema attacks in patients 12 years old and older who have hereditary angioedema.

Drug manufacturer Novo Nordisk said the approval establishes Ozempic as the most broadly indicated GLP-1 RA in its class.

The approval makes Enhertu (fam-trastuzumab deruxtecan-nxki) the first HER2-directed therapy in the United States for treating HER2-low or HER2-ultralow metastatic breast cancer.

FDA has approved an additional indication for LEQEMBI (lecanemab-irmb) as a once-every-four-weeks maintenance therapy for early Alzheimer’s disease.

Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.