Regulatory Filings and Submissions

AstraZeneca Gains FDA Nod for Ultomiris, a Treatment for Managing NMOSD

March 29, 2024

FDA has approved AstraZeneca's Ultomiris, marking the first and only long-acting C5 complement inhibitor for patients with NMOSD.

AbbVie Gains Landos Biopharma and Full FDA Approval for ADC Product

March 28, 2024

The Landos acquisition adds a lead asset in autoimmune and inflammatory disease to AbbVie's portfolio, while the company's ADC, ELAHERE, gets full FDA approval.

FDA Greenlights Orchard Therapeutics' Gene Therapy for Children's MLD; AGC Biologics Selected for Manufacturing

March 20, 2024

FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.

FDA Gives Guidance on Developing Treatments for Early Alzheimer’s

March 15, 2024

The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.

EMA Validates Parallel Applications for Datopotamab Deruxtecan in Two Types of Cancer

March 08, 2024

EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.

EMA Recommends New ALS Treatment

February 27, 2024

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

FDA Approves Amtagvi, First Cell Therapy for Skin Cancer

February 20, 2024

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

EMA Accepts Three Organizations into ATMP Pilot Program

February 09, 2024

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

AbbVie Gains Nod from NICE for Tepkinly

February 04, 2024

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.

FDA Issues Guidance on CAR-T Cell Product Development

February 01, 2024

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.