FDA
Bluebird bio reported first-quarter earnings, the approval of Abecma, the first CAR-T therapy for relapsed or refractory multiple myeloma, and its spinout, 2seventy bio, and its leadership.
Less than two weeks after receiving the greenlight for Zynlonta under accelerated approval, ADC Therapeutics has launched its treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
With Biogen’s potential treatment for Alzheimer’s, aducanumab, coming in weeks before a U.S. FDA decision, ICER wrote a punishing report slamming the drug for insufficient efficacy and recommending a low price point if approved.
The U.S. FDA approved Keytruda combined with Genentech’s Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
BioSpace takes a look at data released this week from some of the numerous ongoing clinical studies to advance potential therapies and treatment for disease. Here are some of them.
The U.S. FDA cites concerns regarding clinical data for ChemoCentryx’s investigational rare autoimmune disease therapy avacopan. Shares in the company plunged 46.5% lower following the release of the document.
Please check out the biopharma industry’s COVID-19 stories that are trending for May 4, 2021.
Sarepta Therapeutics announced Monday that its next-generation PPMO candidate, SRP-5051, showed promise in a Phase II trial when used as a treatment for Duchenne muscular dystrophy in patients amenable to exon 51 skipping.
The U.S. FDA is expected to give the go-ahead for Pfizer and BioNTech’s COVID-19 vaccine for adolescents ages 12 and older within the week.
The U.S. FDA approved Chiesi Global Rare Diseases’ Ferriprox for treatment of transfusional iron overload caused by sickle cell disease (SCD) or other anemias in adults and children ages three years and older. This approval expands the use of the drug for patients with SCD or other anemias.
PRESS RELEASES