The U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of Takeda Pharmaceutical Company Limited’s maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease withgenotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.
Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.
AbbVie Inc. said on Sept. 28 the U.S. health regulator approved the company’s once-daily oral medicine Qulipta for the preventive treatment of migraine in adults, adding a third product to the drugmaker’s arsenal of therapies for severe headaches.
New York-based Intra-Cellular Therapies published the results of the company’s Study 404 phase III trial of lumateperone as monotherapy for major depressive episodes associated with bipolar I or bipolar II disorder.
As the fraud trial of Theranos founder Elizabeth Holmes headlines the pharma legal news, other court-related cases are taking place, including a ruling in the legal spat between Takeda and AbbVie over a supply agreement for the prostate cancer drug Lupron.
The U.S. Centers for Disease Control and Prevention (CDC) on Sept. 24 backed a booster shot of the Pfizer and BioNTech Covid-19 vaccine for Americans aged 65 and older, adults with underlying medical conditions and adults in high-risk working and institutional settings.
The U.S. Food and Drug Administration on Sept. 21 approved Incyte Corp.’s cream Opzelura for treating the inflammatory skin condition atopic dermatitis, commonly called eczema, in adolescents and adults with boxed warnings.
Shares of Verrica Pharmaceuticals plunged after the company received a Complete Response Letter from the U.S. Food and Drug Administration for an experimental treatment for molluscum contagiosum (molluscum).
Genmab A/S and Seagen Inc. announced that the U.S. Food and Drug Administration granted accelerated approval to Tivdak (tisotumab vedotin-tftv), the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Advisers to the U.S. Food and Drug Administration voted on Sept. 17 to recommend Covid-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.