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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The U.S. Food and Drug Administration (FDA) approved Shire’s Takhzyro (lanadelumab-flyo) injection to prevent attacks of hereditary angioedema (HAE) in people 12 years of age and older. The drug was accepted while under priority review.
Shares of AbbVie are inching up this morning after the company announced it had secured regulatory approval for Imbruvica as a treatment for patients with a rare blood disease.
This week has several action dates by the U.S. Food and Drug Administration (FDA) for a range of indications, including acne, intra-abdominal infections, and rare liver diseases. Here’s a look.
There’s been another milestone in the history of biotech: The world’s first RNAi gene-silencing drug, Alnylam Pharmaceuticals’ Onpattro, got approved on August 10. That makes 2018 a landmark year. But another year—2014—may prove just as influential for the field and how it develops.
Shire plc snagged approval from the U.S. Food and Drug Administration for Takhzyro (lanadelumab-flyo), a prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
The U.S. Food and Drug Administration (FDA) cleared Cleveland-based SPR Therapeutics’ SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems for controlling pain.
The U.S. Food and Drug Administration (FDA) granted Merck & Co.’s Keytruda another approval, this one in combination with Alimta (pemetrexed) and platinum chemotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
It’s a busy week on the U.S. Food and Drug Administration (FDA)’s calendar, although the agency got ahead of itself and approved three of the applications early. Here’s a look.
The U.S. Food and Drug Administration has done another about-face. Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA has now approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
The U.S. Food and Drug Administration (FDA) gave Bristol-Myers Squibb’s Opdivo (nivolumab) approval for metastatic small cell lung cancer (SCLC) for patients whose cancer has progressed after platinum-based chemotherapy and at least one other type of therapy.