FDA
New Life told FDA inspectors that they lacked the authority to enter parts of a facility where it made the GLP-1 receptor agonists semaglutide and tirzepatide.
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BioSpace looks back at 2025 and where the FDA is going in 2026.
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
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This approval marks the first treatment indicated for reducing mortality risk in patients with the rare disorder known as molybdenum cofactor deficiency (MoCD) Type A.
The company has agreed to deliver 100 million doses of the vaccines by the end of June.
The end of February and beginning of March is a busy time for the U.S. Food and Drug Administration, with a number of PDUFA dates on the calendar.
The U.S. FDA approved Sarepta Therapeutics’ Amondys 45 (casimersen) for patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 45 skipping.
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.