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The FDA has delayed its target decision date for Orca Bio’s blood cancer cell therapy candidate Orca-T by three months to July 6 after the company submitted additional CMC-related data.

The labor union of Samsung Biologics has secured the votes needed to strike, signaling a potential escalation in an impasse over what the union has branded “[u]nresolved governance failures and rigid labor

The new company, looking to eliminate costly manufacturing bottlenecks by producing biologic medicines in chicken eggs, has now lined up a commercial taker.

With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies.

UCB will build a new manufacturing facility near its U.S. headquarters in Atlanta, Georgia. It will become the first major manufacturing facility in the U.S. for the rapidly growing Belgium-based company and

Despite policy uncertainties in recent years, WuXi Biologics’ emphasis on its U.S. operations continued to pay off in 2025, with the States accounting for a major portion of the record number of

Wilmington PharmaTech, a CDMO specializing in churning out complex custom APIs for small molecules, will drop $50 million in a move to double the current production capacity at its Delaware facility.

India’s Strides Pharma issued a voluntary recall for 89,592 bottles of liquid ibuprofen pain medication for children following reports of contamination.

Axplora, a German CDMO that specializes in specialty active pharmaceutical ingredients for small molecules and antibody-drug conjugates, will shell out $60 million to expand its Farmabios manufacturing facility in Gropello Cairoli, Italy.

Sandoz has struck a deal with Samsung Bioepis to commercialize up to five biosimilars, with the first being SB36, a copycat of Takeda’s Entyvio, which is being developed by the South Korea-based