Regulatory Filings and Submissions

European Commission Approves Metastatic Colorectal Cancer Monotherapy

June 27, 2024

Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.

Sarepta’s Elevidys for Duchenne Muscular Dystrophy Gets Expanded FDA Approval

June 26, 2024

Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.

argenx Gets FDA Nod for VYVGART Hytrulo in CIDP Indication

June 26, 2024

FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.

AstraZeneca mAb Approved by FDA for Endometrial Cancer Patients

June 20, 2024

Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.

CDER Announces Emerging Drug Safety Technology Meeting Program

June 10, 2024

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

Using RWD in Non-Interventional Studies

June 05, 2024

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

Sanofi Gets Priority Review Status for sBLA Seeking Approval of Sarclisa in Combination Therapy for Multiple Myeloma

May 30, 2024

FDA granted priority review to Sanofi's sBLA for Sarclisa in combination with VRd in treating transplant-ineligible patients who are newly diagnosed with multiple myeloma.

FDA Approves Interchangeable Biosimilar to Soliris

May 30, 2024

Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

Novartis’ Radioligand Therapy Gains FDA Nod for Pediatric Patients

April 24, 2024

FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.

Making Lifecycle Management More Efficient in Europe

April 02, 2024

Plans to update the European Union’s variation framework have been finalized.