FDA
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
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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.
Bluebird bio reported first-quarter earnings, the approval of Abecma, the first CAR-T therapy for relapsed or refractory multiple myeloma, and its spinout, 2seventy bio, and its leadership.
Less than two weeks after receiving the greenlight for Zynlonta under accelerated approval, ADC Therapeutics has launched its treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
With Biogen’s potential treatment for Alzheimer’s, aducanumab, coming in weeks before a U.S. FDA decision, ICER wrote a punishing report slamming the drug for insufficient efficacy and recommending a low price point if approved.