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Pharmaceutical Industry News

Along with promoting an autism…

September 22nd, 2025|Fierce Pharma|

Along with promoting an autism symptom treatment in GSK's Wellcovorin (leucovorin), the FDA issued a letter to physicians warning against Tylenol use during pregnancy as updates its safety label to include a potential link to

The FDA has issued a complete…

September 22nd, 2025|Fierce Pharma|

The FDA has issued a complete response letter to Lundbeck and Otsuka, scuppering their ambition to launch the atypical antipsychotic Rexulti—in combination with Viatris’ Zoloft—as a novel treatment for post-traumatic stress disorder.

Health officials are expected to…

September 22nd, 2025|Fierce Pharma|

Health officials are expected to link Tylenol use during early pregnancy to autism and propose a potential treatment in leucovorin, a med used to counter the toxicity of certain chemotherapies, according to the newspaper.

With a Sept. 29 deadline looming…

September 22nd, 2025|Fierce Pharma|

With a Sept. 29 deadline looming for pharmaceutical companies to adhere to President Donald Trump’s most favored nation drug pricing system in the U.S., Bristol Myers Squibb has revealed that it will offer schizophrenia drug

FDA OKs New Keytruda Shot for Cancer

September 19th, 2025|The New York Times|

The F.D.A. approved Merck’s injected version of its blockbuster infusion Keytruda. The company says it will be quicker and easier, but it stands to slow the adoption of cheaper competitors and increase costs by billions

After a tumultuous journey filled…

September 19th, 2025|Fierce Pharma|

After a tumultuous journey filled with delays and rejection, the FDA has approved Stealth BioTherapeutics’ treatment for the ultrarare disease Barth syndrome, marking the peptide as the first therapy for the condition.

As AI plays an increasingly…

September 19th, 2025|Fierce Pharma|

As AI plays an increasingly important role in health and pharma marketing, leaders at agencies and organizations who spoke with Fierce Pharma Marketing pointed to a remarkably diverse number of ways the technology is having

In the second and final day of the…

September 19th, 2025|Fierce Pharma|

In the second and final day of the CDC’s Advisory Committee on Immunization Practices September meeting, members of the panel scrapped one vote, reversed another and stopped just short of endorsing a third that had

The FDA has approved Merck &…

September 19th, 2025|Fierce Pharma|

The FDA has approved Merck & Co.’s under-the-skin version of Keytruda, reducing treatment time burden for patients while granting the world’s best-selling drug potential blockbuster revenue protection.

Takeda employees from around the…

September 19th, 2025|Fierce Pharma|

Takeda employees from around the world climbed Mount Fuji, a challenge that was meant not only to represent and celebrate the recent rollout of several of the company’s PDTs in Japan but also to raise

The CDC’s recommendation for…

September 19th, 2025|Fierce Pharma|

The CDC's recommendation for Gilead's twice-yearly Yeztugo as an HIV PrEP option was hailed by HIV advocacy groups but stirred up pressure for CVS Health to include the drug on its formularies.

Europe’s Committee for Medicinal…

September 19th, 2025|Fierce Pharma|

Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended several drugs for approval, including Novo Nordisk's once-weekly diabetes drug Kyinsu and Bayer's menopause treatment Lynkuet.

Freda Lewis-Hall, M.D., former…

September 19th, 2025|Fierce Pharma|

Freda Lewis-Hall, M.D., former Pfizer chief medical officer, joins "The Top Line" to discuss rebuilding patient trust, listening before messaging and what it means to put a human face on pharma.

The lawsuits were part of the…

September 19th, 2025|Fierce Pharma|

The lawsuits were part of the large web of COVID-19 vaccine patent infringement cases filed against—and by—the most prominent vaccine makers.

In a perplexing conclusion to an…

September 18th, 2025|Fierce Pharma|

In a perplexing conclusion to an oftentimes tense meeting of the CDC’s Advisory Committee on Immunization Practices Thursday, the panelists—assembled recently in the aftermath of Robert F. Kennedy Jr.’s purge of the committee—seemed to contradict