Industry News

Pharmaceutical Industry News

The FDA’s Commissioner’s National…

May 6th, 2026|Fierce Pharma|

The FDA's Commissioner's National Priority Voucher program has been steeped in controversy since its inception. Now, Sanofi has asked that one of its applications be taken out of the fast-track program, according to Stat.

In a bid to better deploy its…

May 6th, 2026|Fierce Pharma|

In a bid to better deploy its boots-on-the-ground resources, the FDA is rolling out a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to complement its traditional site visits.

After several consecutive quarters…

May 6th, 2026|Fierce Pharma|

After several consecutive quarters on the backfoot, Danish drug juggernaut Novo Nordisk is receiving warmer feedback on its starting performance in 2026, thanks in no small part to its head start over rival Eli Lilly

The FDA-conducted studies…

May 6th, 2026|Fierce Pharma|

The FDA-conducted studies reportedly found COVID vaccines and GSK's shingles vaccine Shringrix safe and effective, according to The New York Times.

Cell and gene therapy developers…

May 6th, 2026|Fierce Pharma|

Cell and gene therapy developers must build continuity of engagement to create trust in the modalities, according to a report by Bayer’s venture capital wing.

Following a series of “most…

May 6th, 2026|Fierce Pharma|

Following a series of “most favored nation” pricing deals with 17 large pharma companies, the Trump administration released a report Tuesday projecting potential $529 billion in savings from the policy over the next 10 years.  

Last month, when Optimi…

May 6th, 2026|Fierce Pharma|

Last month, when Optimi Health kicked off an initial public offering of 2.5 million shares, the timing couldn’t have been better for the Vancouver-based manufacturer of psychedelic drugs. With President Donald Trump recently signing an executive order

With commitments to invest more…

May 6th, 2026|Fierce Pharma|

With commitments to invest more than $50 billion in building up its U.S. manufacturing presence, Eli Lilly has earmarked an additional $4.5 billion to upgrade two of its three planned production facilities in Lebanon, Indiana.

As the promotion battle between…

May 6th, 2026|Fierce Pharma|

As the promotion battle between old rivals Novo Nordisk and Eli Lilly heats up, regulators in France are reminding the world’s two biggest obesity drugmakers what happens when promotion goes too far.

With a better-than-expected first…

May 5th, 2026|Fierce Pharma|

With a better-than-expected first quarter in the books, Pfizer—continuing to grapple with the post-pandemic overhang from its COVID-19 franchise—is sticking with the sales forecast it set earlier this year, raising questions from at least one

Novartis is continuing its…

May 5th, 2026|Fierce Pharma|

Novartis is continuing its multiyear overhaul with new plans to shutter its production facility in Wehr, Germany, by 2028. The move, announced Tuesday, will eliminate about 220 jobs, according to Novartis.

The German vaccine maker plans to…

May 5th, 2026|Fierce Pharma|

The German vaccine maker plans to wind down operations at a handful of its sites in Germany plus one in Singapore, putting as many as 1,860 jobs on the chopping block.

Fresh off gaining an FDA expansion…

May 5th, 2026|Fierce Pharma|

Fresh off gaining an FDA expansion for Auvelity as a treatment for agitation associated with Alzheimer’s disease, Axsome Therapeutics has projected peak sales for the non-antipsychotic drug to reach $8 billion.

Sanofi is supercharging its…

May 5th, 2026|Fierce Pharma|

Sanofi is supercharging its artificial intelligence capabilities. The French pharma is investing $294 million to expand its global AI center of excellence in Toronto, kicking off a scale-up of the digital infrastructure it built at