Industry News

Pharmaceutical Industry News

Moderna has early in-human data…

September 23rd, 2025|Fierce Pharma|

Moderna has early in-human data showing its next-generation COVID-19 vaccine, mNEXSPIKE, has the potential to offer strong immune protection against the latest rapidly spreading SARS-CoV-2 virus variant.

Celltrion—which specializes in…

September 23rd, 2025|Fierce Pharma|

Celltrion—which specializes in biosimilar drugs—has inked an agreement to purchase Eli Lilly’s drug substance plant in Branchburg, New Jersey, for 460 billion Korean won ($330 million), according to a Sept. 23 shareholder letter. The deal

Scholar Rock’s bid to win the…

September 23rd, 2025|Fierce Pharma|

Scholar Rock’s bid to win the first FDA approval for a muscle-targeted treatment for spinal muscular atrophy has been tripped up by inspection issues at a former Catalent production site in Indiana, now owned by

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