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Pharmaceutical Industry News

With an eye on the lucrative U.S….

May 7th, 2026|Fierce Pharma|

With an eye on the lucrative U.S. market, Italy’s Angelini Pharma will acquire rare disease specialist Catalyst Pharmaceuticals and its potential blockbuster Firdapse for $4.1 billion.

After a surprise rejection in…

May 7th, 2026|Fierce Pharma|

After a surprise rejection in January, the FDA has agreed to reconsider a T-cell therapy based on the same single-arm trial that the agency had previously found problematic. The case could reignite investors’ hope of

The FDA has hit Alnylam with an…

May 7th, 2026|Fierce Pharma|

The FDA has hit Alnylam with an untitled letter over the consumer website for Amvuttra, accusing the biotech of presenting open-label data that create a misleading impression of the drug’s effects.

Insulet has always been a strong…

May 7th, 2026|Fierce Pharma|

Insulet has always been a strong leader in the medtech industry when it comes to its marketing game—and the diabetes device maker isn’t looking to rest on its laurels.

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.