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Pharmaceutical Industry News

The FDA signed off on Imfinzi as…

November 25th, 2025|Fierce Pharma|

The FDA signed off on Imfinzi as the first immunotherapy that can treat certain patients with early-stage stomach cancer both before and after surgery, marking the drug's third perioperative nod.

Nominate up-and-coming…

November 25th, 2025|Fierce Pharma|

Nominate up-and-coming early-career pharma marketing pros here to be featured in Fierce's "Rising Stars" Q&A series.

Sarepta will study its gene…

November 25th, 2025|Fierce Pharma|

Sarepta will study its gene therapy Elevidys with the immunosuppressant sirolimus in non-ambulatory patients with Duchenne muscular dystrophy in the hopes of quelling the liver safety issues that led to a label restriction.

A short film that premiered…

November 25th, 2025|Fierce Pharma|

A short film that premiered earlier this month follows three people who, after being diagnosed with chronic lymphocytic leukemia, discover a renewed commitment to living their lives to the fullest.

A survey has found that pharma…

November 25th, 2025|Fierce Pharma|

A survey has found that pharma marketing and promotional review professionals are skeptical of the outputs of artificial intelligence models, with 65% of respondents saying they don’t trust the technology to create regulatory compliance submissions.

Novartis has received an FDA…

November 25th, 2025|Fierce Pharma|

Novartis has received an FDA approval for Itvisma, an intrathecal version of the company’s gene therapy Zolgensma, to treat older patients with spinal muscular atrophy.

Less than a week after Novartis…

November 25th, 2025|Fierce Pharma|

Less than a week after Novartis unveiled a plan to establish a “flagship manufacturing hub” in North Carolina that would add 700 employees to its rolls, the Swiss drugmaker says it is making moves in

The PMCPA has ruled that a…

November 25th, 2025|Fierce Pharma|

The PMCPA has ruled that a presentation calling the European Medicines Agency “stupid” brought discredit on the pharma industry.

A few months after SK Life Science…

November 24th, 2025|Fierce Pharma|

A few months after SK Life Science began rolling out a road trip-themed TV commercial for its antiseizure medication Xcopri, the FDA is attempting to put the brakes on the ad.

Novo Nordisk has come up short in…

November 24th, 2025|Fierce Pharma|

Novo Nordisk has come up short in two phase 3 trials of semaglutide as a treatment for Alzheimer’s disease. But perhaps the larger story associated with the unsurprising result is the market reaction, as Novo's

A combination of Merck-partnered…

November 24th, 2025|Fierce Pharma|

A combination of Merck-partnered sac-TMT and Keytruda led to a “statistically significant and clinically meaningful” improvement in progression-free survival versus Keytruda alone in a phase 3 trial in first-line PD-L1-positive NSCLC, Kelun said Monday.

Eli Lilly’s latest high-profile…

November 21st, 2025|Fierce Pharma|

Eli Lilly's latest high-profile crossovers—which include a starry TV partnership and the far-reaching rollout of a new campaign—both tie into the drugmaker’s work to draw more attention to Alzheimer’s disease.

Maryland is becoming the home away…

November 21st, 2025|Fierce Pharma|

Maryland is becoming the home away from home for British drugmaker AstraZeneca. On Friday, the biopharma powerhouse upped its ante in the Old Line State, saying it will invest $2 billion to increase its manufacturing

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.