Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
Novavax said the Food and Drug Administration allowed it to continue testing a combination COVID-19-flu and standalone flu vaccine that had been put on hold.
FiercePharma4h
Autolus readies its CAR-T Aucatzyl to go after heavy hitter competition following FDA nod
Watch out, Gilead and Novartis: there's a new CAR-T in town. Autolus is ready to hit the ground running after winning FDA approval for its Aucatzyl, a late entry to the heated CD19 CAR-T cell therapy ...
From AI to Musk’s brain chips, the FDA’s device unit faces rapid change
The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
As AI Transforms Drug Development, FDA Is Scrambling to Figure Out Guardrails
Since 2016, the Food and Drug Administration has received about 300 drug submissions that reference artificial intelligence, ...
Morningstar2d
Autolus Therapeutics Gets FDA Approval for Cancer Treatment
Autolus Therapeutics said it received Food and Drug Administration approval of its treatment of acute lymphoblastic leukemia, or ALL, an aggressive blood and bone marrow cancer, for certain patients.
Autolus wins FDA approval of Aucatzyl for acute lymphoblastic leukemia
FDA approves Autolus Therapeutics' Aucatzyl for adults with relapsed or refractory B-cell precursor acute lymphoblastic ...
Medscape3d
Why a Failed Confirmatory Trial May Not Mean a Failed Drug
there are 64 oncology drug indications on the US market with accelerated approvals only. The FDA estimates the accelerated ...
Crain's Chicago Business3d
Behind burgeoning diabetes treatment, dueling UChicago and UIC profs
At the center of this fight is how the FDA regulates a possible "functional cure" for Type 1 diabetes and determines who gets ...
After decades, FDA finally moves to pull ineffective decongestant off shelves
In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...
News Medical6d
No evidence Trump’s drug program for terminal patients saved ‘thousands’ of lives
Former President Donald Trump has boasted in recent months about "Right To Try," a law he signed in 2018. It's aimed at ...
FierceBiotech6d
FDA delays decision on Merus' first-in-class cancer drug by 3 months
The FDA has scuttled Merus’ plans to win a speedy approval for i | The FDA has scuttled Merus’ plans to win a speedy approval ...