Industry News

Pharmaceutical Industry News

The FDA has opened an…

November 21st, 2025|Fierce Pharma|

The FDA has opened an investigation into Takeda’s recombinant protein med Adzynma following the reported death of a pediatric patient who received the drug.

Cosette had been attempting to…

November 21st, 2025|Fierce Pharma|

Cosette had been attempting to invalidate its $430 million buyout of Australia's Mayne Pharma since May and has now seen its wish granted based on a national security concern from the Australian government.

Some four years into Jemperli’s…

November 21st, 2025|Fierce Pharma|

Some four years into Jemperli’s commercial life span, a rift has emerged between GSK subsidiary Tesaro and the potential cancer blockbuster’s original developer, AnaptysBio.

A Novo Nordisk challenge has…

November 21st, 2025|Fierce Pharma|

A Novo Nordisk challenge has driven Regen Doctors to voluntarily discontinue compounded semaglutide product claims, adding to the Danish drugmaker’s string of wins against companies selling versions of its GLP-1 blockbuster.

The commercial effects of an…

November 20th, 2025|Fierce Pharma|

The commercial effects of an emboldened anti-vaccine movement in the U.S. were evident in the third quarter as several companies reported declining vaccine sales.

Changes to a public health webpage…

November 20th, 2025|Fierce Pharma|

Changes to a public health webpage undercut the medical community's consensus rebuke of childhood vaccines as a cause of autism. They were swiftly condemned by public health advocates and the Senate's top healthcare legislator.

In an effort to break even by…

November 20th, 2025|Fierce Pharma|

In an effort to break even by 2028, mRNA specialist Moderna is laying out a three-year business strategy, highlighting promising avenues for growth and setting out a goal to lift revenue by up to 10%

A new report finds China supplies…

November 20th, 2025|Fierce Pharma|

A new report finds China supplies many key pharmaceutical ingredients to the U.S. market. Bayer opened a new biotech incubator in Beijing. A first-of-its-kind biosimilar originally developed by Shanghai Henlius Biotech scored FDA approval. And

Pfizer and manufacturer Tris…

November 20th, 2025|Fierce Pharma|

Pfizer and manufacturer Tris Pharma were accused in 2023 of previously providing ADHD med Quillivant through the Texas Medicaid program despite knowing that the drug failed quality control tests during production.

After months of back-and-forth…

November 20th, 2025|Fierce Pharma|

After months of back-and-forth with the FDA and a third-party manufacturer, Regeneron has secured two long-awaited approvals for Eylea HD, gaining a new indication and a more flexible dosing option for the eye disease drug.

Cdymax Pharma has been slapped…

November 20th, 2025|Fierce Pharma|

Cdymax Pharma has been slapped with a warning letter from the FDA outlining two observations against the Bangalore, India-based API maker, both linked to testing shortfalls.

Bayer’s Hyrnuo is catching up to…

November 19th, 2025|Fierce Pharma|

Bayer's Hyrnuo is catching up to Boehringer Ingelheim's rival Hernexeos with an accelerated approval to treat a rare tumor type in certain patients with non-small cell lung cancer.

With a $140 million investment,…

November 19th, 2025|Fierce Pharma|

With a $140 million investment, Moderna will build a new facility at its manufacturing campus in Norwood, Massachusetts. The new plant will allow the company to execute end-to-end clinical- and commercial-stage production of its mRNA

Antheia is teaming up with…

November 19th, 2025|Fierce Pharma|

Antheia is teaming up with TAPI—Teva’s active pharmaceutical ingredient and contract manufacturing business—in a bid to further commercialize its pipeline of biosynthetic drug ingredients and key start materials.

Novartis expect the expansion in…

November 19th, 2025|Fierce Pharma|

Novartis expect the expansion in North Carolina will add 700 new employees to its ranks. The manufacturing campus will span some 700,000 square feet between new and existing space, Novartis said.

Two months after Celltrion bought…

November 19th, 2025|Fierce Pharma|

Two months after Celltrion bought a U.S. manufacturing facility from Eli Lilly for $330 million, the South Korean biosimilar specialist said it will spend another 700 billion won ($478 million) to upgrade the plant.