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New Drug Approvals

MUMBAI, India and PRINCETON, N.J., July 26, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: S...
FDA Daily Update

This week, the FDA published final guidance on glass vials and stoppers, OTC monograph submissions and real-world data. Draft guidance was issued o...
FDA Daily Update

A supplemental BLA for AstraZeneca’s blockbuster cancer drug Imfinzi (durvalumab) for treatment of nonsmall-cell lung cancer (NSCLC) hit a potentia...
FDA Daily Update

A federal grand jury in Houston has indicted an Indian national with selling and shipping tens of thousands of dollars’ worth of counterfeit oncolo...
FDA Daily Update

FDA issued a Warning Letter to Criticare Technologies for failure to investigate complaints that its nGenuity patient vital signs monitor — which c...
Clinical Trial Results

SEATTLE, July 25, 2024. Presage Biosciences, a biotechnology company that directly measures activity of oncology drugs within human tumors, announc...
FDA Daily Update

Members of the House Committee on Oversight and Accountability grilled the leaders of the nation’s three largest pharmacy benefit managers (PBM) — ...
FDA Daily Update

Guardant Health has agreed to pay $900,000 to settle allegations that it participated in a scheme with a physician to submit charges to Medicare in...
FDA Daily Update

In this edition of Quick Notes, we cover a workshop on psychedelics, regulations on substances of human origin, selection of the COVID-19 strain fo...
FDA Daily Update

Jeff Shuren, currently Director of CDRH, has announced that he is leaving the agency after 28 years of service including 15 years as the director.
New Drug Approvals

On July 22, 2024, the U.S. Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disin...
Drugs FDA Alerts

Audience: Healthcare Provider, Pharmacy, Consumer July 18, 2024 – East Windsor, New Jersey. Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is...