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.
FEATURED STORIES
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.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Shares of Heron Therapeutics climbs after it announced the U.S. FDA approved its non-opioid drug for extended pain relief following some surgeries.
Pivotal data from Amgen’s and AstraZeneca’s NAVIGATOR Phase III trial show tezepelumab, a potential first-in-class human monoclonal antibody, reduced asthma aggravations and exacerbations requiring hospitalizations better than placebo in patients with severe asthma.
There was a lot of news and research studies today related to the COVID-19 vaccines. Here’s a look.
Merck announced positive results from the late-stage KEYNOTE-522 study that should support its previous attempt that was stymied by a regulatory advisory committee in February and rejected by the U.S. FDA in March.
Clearance of the IND allows Samus to proceed with a Phase Ib trial to assess the safety, tolerability and pharmacokinetics of PU-AD in a small group of patients with recurrent malignant glioma.
The U.S. FDA expanded the Emergency Use Authorization for the Pfizer and BioNTech vaccine to include adolescents ages 12 to 15 after clinical data showed 100% efficacy response.
May is a busy month for the U.S. Food and Drug Administration (FDA)’s calendar for new drug reviews. Here’s a look.
A final analysis of AstraZeneca’s Phase III POSEIDON trial shows IMFINZI (durvalumab), offered improvements in overall survival (OS) when added to tremelimumab and chemotherapy versus chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer.
The FDA released a briefing document that expressed concerns over ChemoCentryx’s avacopan. Company shares plummeted 46.5% at the news.
Six months after receiving Emergency Use Authorization from the U.S. FDA for COVID-19 vaccines, Pfizer/BioNTech and Moderna are planning to seek full approval for the preventative medications.