Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

The Consolidated Appropriations Act for 2023 provides FDA with a $6.6 billion total budget.

Massive Government Spending Bill Tackles Key FDA and Research Issues

The complaint states the company introduced adulterated drugs into interstate commerce that were manufactured, processed, packed, or held under conditions that defy current good manufacturing practice (CGMP) requirements. 

Consent Decree Against Oklahoma Drug Compounder Enters Federal Court

Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi). 

Bylvay Alagille Syndrome Submitted for Regulatory Filings to FDA, EMA

The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.



Marketing Authorization Application Accepted for Sugemalimab in Metastatic Non-small Cell Lung Cancer

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US. 

FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

Sosei Heptares and Eli Lilly have entered a multi-target collaboration and license agreement in diabetes and metabolic diseases. 

Sosei Heptares and Eli Lilly Enter Multi-target Collaboration

The launch of Discovery Life Sciences’ new Proteomic Services Division offers a single source for large-scale population studies, biobank characterization, and multi-omic biomarker analysis.

Discovery Life Sciences Now Offers Large-Scale Proteomic Services

GSK and Wave Life Sciences have entered into a collaboration to drive drug discovery and development for novel genetic targets.

GSK and Wave Life Sciences to Collaborate on Oligonucleotide Therapeutics

AbCellera and Rallybio are teaming up to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases.

AbCellera and Rallybio Partner on Novel Antibody-Based Therapeutics

Catalent is set to expand its biologics analytical services with its new facility in Durham, NC. 

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