FDA
Several biopharma companies celebrate the U.S. Food and Drug Administration’s approval for clinical trials involving therapeutics for cancer treatment.
FEATURED STORIES
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The U.S. Food and Drug Administration has approved AbbVie’s biologic therapy HUMIRA® (adalimumab) as a treatment for moderate-to-severe active ulcerative colitis in children aged 5 years and older.
The date set by the FDA’s independent advisors for debating that decision is Friday, February 26.
On Monday, the companies announced their checkpoint inhibitor Libtayo (cemiplimab-rwlc) won Food and Drug Administration approval for lung cancer.
The U.S. FDA granted Amgen Priority Review for sotorasib for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), after at least one previous systemic therapy.
The U.S. Food and Drug Administration (FDA) approved G1 Therapeutics’ Cosela (trilaciclib) for injection to decrease the damage to the immune system and bone marrow from chemotherapy.
The U.S. Food and Drug Administration (FDA) has several solid PDUFA dates in the middle of February. Here’s a look.
The U.S. FDA approved Regeneron’s monoclonal antibody Evkeeza (evinacumab-dgnb) as an add-on treatment for adult and pediatric patients ages 12 and above with homozygous familial hypercholesterolemia (HoFH).
The U.S. FDA has approved Regeneron and Sanofi’s PD-1 inhibitor Libtayo® for the treatment of patients with advanced basal cell carcinoma with a history of treatment with a hedgehog pathway inhibitor or in patients with advanced BCC who are considered ineligible for an HHI.
This combination therapy has been authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Bristol Myers picked up the therapy when it acquired Celgene in 2019 for $74 billion.