Shares of MEI Pharma Inc. plunged more than 60% in trading on March 25 after the company announced that additional clinical research will be needed in order for the its phosphatidylinositol-3-kinase (PI3K) inhibitor zandelisib to be considered for regulatory approval.
Bristol Myers Squibb’s blockbuster cancer drug Revlimid finally has a competitor as Teva Pharmaceuticals announced the launch of a generic version of Revlimid, which could significantly cut into the global biopharmaceutical company’s earnings.
The U.S. Food and Drug Administration is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib), which is indicated for two types of lymphoma.
Incyte Corporation withdrew the New Drug Application (NDA) for the company’s candidate drug for various types of lymphoma.
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.
Novartis CAR-T cell therapy Kymriah met the primary endpoint at an interim analysis of a phase II trial in patients with relapsed or refractory follicular lymphoma, the Swiss drugmaker said.
Shares of Epizyme stock rose after the company’s first-in-class EZH2 inhibitor Tazverik won approval from the U.S. Food and Drug Administration for the second time in 2020.
A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
Celgene Corporation announced the U.S. Food and Drug Administration approved Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma or marginal zone lymphoma following Priority Review designation.
Pfizer Inc. announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera (rituximab-EU), met its primary endpoint.