Food and Drug Administration (FDA)
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The U.S. Food and Drug Administration said that data from BrainStorm Cell Therapeutics’ ALS Phase III trial does not meet the threshold of substantial evidence needed to support a BLA for the company’s ALS NurOwn therapy.
In an editorial letter in The New England Journal of Medicine, Jeff Shuren, M.D., the FDA’s device center director, and the agency’s in vitro diagnostics chief Timothy Stenzel, M.D., Ph.D., wrote that the agency planned to revisit their policy on antibody testing after it had authorized several serology tests.
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.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 16, 2021.
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.
The U.S. FDA Oncologic Drugs Advisory Committee voted against recommending the drug as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery, at least for now.
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