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On May 19, 2023, Krystal Biotech, a client of Berkshire Sterile Manufacturing (BSM), received FDA approval for VYJUVEK™, the first-ever topical gene therapy approved to treat dystrophic epidermolysis bullosa (DEB) in children and adults six months of age or older.

The Ritedose Corporation, the leading contract development and manufacturing organization specializing in sterile Blow Fill Seal production, announces a significant expansion of its production capabilities to meet the demand for ophthalmic and respiratory medications.

A historic transplant of a genetically modified pig heart has been successfully performed on a 20-year Navy veteran and married father of two suffering from end-stage cardiovascular disease.

Companies are announcing significant investments in U.S. manufacturing in response to looming tariffs. An AstraZeneca executive and Eli Lilly and Novo Nordisk spokespeople discuss potential job and skill-building opportunities and where manufacturing might head in the future.

Major pharmaceutical companies are committing billions to US manufacturing in an effort to avoid steep tariffs threatened by President Donald Trump.

Multiply Labs and Fedegari Group Collaborate to Add Sterilization to Automated Cell Therapy Manufacturing for Eliminating Contamination Risks.

Roche is committing $50 billion while Regeneron inked a $3 billion manufacturing deal with Fujifilm, allowing the pharma to “nearly double” its U.S. large-scale manufacturing capacity.

Berkshire Sterile Manufacturing’s client, Fennec Pharmaceuticals Inc., received FDA approval of their drug product, PEDMARK – a sodium thiosulfate Injection with an indication to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors.