News about Regulation

US FDA Approves Pirtobrutinib for Untreated CLL/SLL

The US FDA has approved Eli Lilly’s pirtobrutinib (Jaypirca) for previously untreated CLL/SLL in adults without known 17p deletion.

Regulation | 05/10/2026 | By News Bureau

US FDA Approves First Drug for Rare Pediatric Heart Condition

The US FDA has approved first drug to improve functional capacity and symptoms in children with rare inherited heart condition.

Regulation | 03/10/2026 | By News Bureau

US FDA Approves AbbVie's JUVMO for Parkinson's Disease

The US FDA has approved AbbVie’s JUVMO (tavapadon) for Parkinson’s Disease (PD), supported by phase 3 TEMPO data showing improved daily function.

Regulation | 30/09/2026 | By News Bureau |  111

US FDA Approves First Treatment for MCT8 Deficiency

The US FDA has approved the first treatment for MCT8 deficiency, designed to bypass the defective transporter and lower elevated blood thyroid hormone levels.

Regulation | 30/09/2026 | By News Bureau

Akums Gets DCGI Nod for Colchicine 0.5 mg Tablets

Akums has received DCGI approval for Colchicine 0.5 mg tablets, marking a first-in-India approval and expanding its cardiovascular therapeutics portfolio.

Regulation | 29/09/2026 | By News Bureau

Symbiotec Pharmalab Receives VAI Status from US FDA

Symbiotec Pharmalab has received a US FDA Establishment Inspection Report with VAI classification for its Pithampur facility following an August 2026 inspection.

Regulation | 29/09/2026 | By News Bureau

Lupin Gets US FDA Tentative Approval for Apixaban Suspension

Lupin has received tentative US FDA approval for Apixaban Oral Suspension 1.25 mg/mL, offering an alternative anticoagulation option for adults who may have swallowing difficulties.

Regulation | 29/09/2026 | By News Bureau |  295

US FDA Approves Atebrioz from Mirum and Incyte

The US FDA has approved Atebrioz (zilurgisertib) from Mirum and Incyte for adult and pediatric patients with Fibrodysplasia Ossificans Progressiva (FOP).

Regulation | 28/09/2026 | By News Bureau

US FDA Approves Lilly's Onswik for Adults Living with T2D

The US FDA has approved Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults with Type 2 Diabetes (T2D).

Regulation | 25/09/2026 | By News Bureau

UK MHRA Approves Lurbinectedin for Extensive-Stage SCLC

The UK MHRA has approved lurbinectedin for adults with extensive-stage Small Cell Lung Cancer, with its safety and effectiveness to remain under close review.

Regulation | 25/09/2026 | By News Bureau