Shares of uniQure NV climbed after the company announced the clinical hold on its hemophilia B gene therapy was lifted by the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration requested that Emergent BioSolutions temporarily pause production of ingredients for the Johnson & Johnson Covid-19 vaccine at their facility in Baltimore.

Less than a month after submitting an Investigational New Drug (IND) application, Anixa Biosciences ran into a snag with the U.S. Food and Drug Administration as the government agency asked for more information before approving a clinical study on the company’s Chimeric Antigen Receptor-T cell therapy (CAR-T).

A U.S. health advisory panel on April 14 is set to review six reported cases of rare blood clots in women who received Johnson & Johnson’s Covid-19 vaccine one day after federal regulators paused the use of the shot to assess the issue.

Trodelvy, Gilead Sciences

The U.S. Food and Drug Administration granted accelerated approval of Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.

The U.S. Food and Drug Administration approved a prefilled syringe for self-injection of the allergic diseases treatment Xolair developed by Novartis and Genentech, a Roche company.

Pfizer Inc. said on April 7 the U.S. Food and Drug Administration extended the review of the company’s experimental atopic dermatitis drug by three months, the latest regulatory setback for a class of treatments known as JAK inhibitors.

Shares of Supernus Pharmaceuticals climbed in trading on April 5 after the U.S. Food and Drug Administration’s April 2 approval of the company’s non-stimulant treatment for attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

The U.S. Food and Drug Administration approved United Therapeutics Corporation’s Tyvaso (treprostinil) Inhalation Solution for the treatment of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

AbbVie

The U.S. Food and Drug Administration accepted AbbVie’s New Drug Application for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist for the preventive treatment of migraine in adults who meet criteria for episodic migraine.