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.
Gilead Company Kite submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
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.
The U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.
U.S. President Joe Biden said on March 29 that 90 percent of all adults in the United States will be eligible for the coronavirus vaccination by April 19 as he warned about the potential for an upsurge in infections.
The U.S. government will distribute 11 million doses of Johnson & Johnson’s COVID-19 shot next week as the company continues to ramp up vaccine production to support the White House’s effort to get 200 million shots in arms in the first 100 days of President Biden’s term, a White House official said on March 26.
Johnson & Johnson will launch the newly approved drug Ponvory for adults with relapsing multiple sclerosis (MS) in the United States during early April 2021 at a similar price point to rival treatments, the company’s Janssen Pharmaceutical unit said on March 19.
President Joe Biden told U.S. states on March 11 to make all adults eligible for a coronavirus vaccine by May 1 and urged Americans to stay vigilant or face more restrictions, hours after he signed a $1.9 trillion stimulus bill into law.
The U.S. Food and Drug Administration granted accelerated approval to Gilead Company Kite’s Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The U.S. Food and Drug Administration approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).