Approvals

FDA proposes risk-based enforcement approach to homeopathic drugs

The US Food and Drug Administration (FDA) is proposing new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs.

CHMP recommends approval of darvadstrocel to treat complex perianal fistulas in Crohn’s disease

Takeda Pharmaceutical and TiGenix reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel).

Aclaris gets FDA nod for Eskata drug to treat raised seborrheic keratoses

Aclaris Therapeutics has secured approval from the US Food and Drug Administration (FDA) for Eskata (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses or SKs.

FDA approves Pfizer’s Xeljanz and Xeljanz XR to treat active psoriatic arthritis

The US Food and Drug Administration (FDA) has approved Pfizer’s Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).

Sanofi’s Admelog (insulin lispro injection) gets FDA approval to treat diabetes

Sanofi’s Admelog (insulin lispro injection) has been approved by the US Food and Drug Administration (FDA) to help diabetic patients control their blood sugar levels at mealtime.

Novo Nordisk’s Ozempic diabetic drug secures FDA approval

Novo Nordisk’s Ozempic (semaglutide injection) has been approved by the US Food and Drug Administration (FDA) to enhance glycaemic control in adults with type 2 diabetes mellitus.

Amgen’s Repatha approved by FDA for heart attack and stroke prevention

Amgen’s cholesterol drug Repatha (evolocumab) has been approved by the US Food and Drug Administration (FDA) to prevent heart attacks, strokes and coronary revascularizations in adults having cardiovascular disease.

Indivior’s Sublocade secures FDA approval to treat opioid use disorder

Indivior’s Sublocade (buprenorphine extended- release) injection has been approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder (OUD).

European Commission approves Tremfya to treat moderate to severe plaque psoriasis

Janssen-Cilag International announced that the European Commission (EC) has approved Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.