FDA
Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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Novartis released new information that showed siponimod consistently reduced the risk of confirmed disability progression in secondary progressive multiple sclerosis (SPMS) patients.
The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) in tumors with epidermal growth factor receptor (EGFR) mutations.
In a stunning about-face the U.S. Food and Drug Administration (FDA) has accepted Alkermes New Drug Application for ALKS 5461. The FDA rejected the NDA at the end of March over a lack of data.
Shares of Rigel Pharmaceuticals shot up about 40 percent during Thursday trading due primarily to an error on the company’s website that claimed its drug candidate Tavalisse had gained approval from the U.S. Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) approved Amgen’s supplemental Biologic License Application (sBLA) for Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) under specific circumstances.
The U.S. Food and Drug Administration (FDA) approved Mylan NV’s Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate) for adult and pediatric HIV-1 patients.This marks the third HIV approval for the company.
The U.S. Food and Drug Administration (FDA) accepted Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) with Yervoy (ipilimumab) for a type of colorectal cancer.
Seattle Genetics announced today that the FDA has granted approval for its Adcetris drug to treat Hodgkins Lymphoma.
The FDA granted a Priority Review designation to Pfizer and partner Astellas Pharma for expanded use of Xtandi in prostate cancer treatment.
On April 23, the FDA’s arthritis advisory committee will take another look at Eli Lilly’s re-submission for their moderate-to-severe rheumatoid arthritis drug.