Industry News

Pharmaceutical Industry News

The FDA has extended its target…

August 20th, 2025|Fierce Pharma|

The FDA has extended its target action dates for two applications to expand the use of Eylea’s high-dose formulation. The U.S. regulator was originally scheduled to make its Eylea HD decisions by Aug. 19, but

Catalent is laying off 350…

August 20th, 2025|Fierce Pharma|

Catalent is laying off 350 employees at its gene therapy manufacturing division in Baltimore “due to an unexpected shift in demand from a large customer, which made it necessary to reduce our workforce,” a spokesperson

A trio of Indian…

August 20th, 2025|Fierce Pharma|

A trio of Indian drugmakers—Alembic, Sun and Glenmark—each issued separate voluntary drug recalls due to either the presence of carcinogens or foreign matter in the products.

With three new antibiotics set to…

August 19th, 2025|Fierce Pharma|

With three new antibiotics set to shake up the stagnant treatment landscape for uncomplicated urinary tract infections in the U.S., Dublin-based Iterum Therapeutics has made it to market first, edging out generics juggernaut Alembic Pharmaceuticals

Several U.S. pharma companies that…

August 19th, 2025|Fierce Pharma|

Several U.S. pharma companies that had posted revenue declines in the first quarter bounced back in the second quarter, including Pfizer, Regeneron and Bristol Myers Squibb. Additionally, Eli Lilly has finally surpassed Novo Nordisk in

The nation’s largest pediatrician…

August 19th, 2025|Fierce Pharma|

The nation's largest pediatrician professional organization urged providers and insurers to consider its evidence-backed vaccine recommendations, as opposed to those coming out of a federal advisory panel the health secretary remade to reflect his skepticism

As its lead candidate advances…

August 19th, 2025|Fierce Pharma|

As its lead candidate advances into a late-stage trial for pulmonary arterial hypertension, Inhibikase Therapeutics has picked up a commercial leader with plenty of experience in the PAH space.

With sales of atopic dermatitis…

August 19th, 2025|Fierce Pharma|

With sales of atopic dermatitis treatment Adbry scaling up in the U.S., Leo Pharma is accomplishing one of the goals established by CEO Christophe Bourdon when he took over at the Danish dermatology specialist in

As it brings a brand beloved in…

August 19th, 2025|Fierce Pharma|

As it brings a brand beloved in Mexico stateside, Bayer is stoking nostalgia and a sense of family and tradition to improve its reach among the Hispanic population in the U.S.

Dogged for several years by an…

August 19th, 2025|Fierce Pharma|

Dogged for several years by an investor lawsuit accusing the company of misleading investors about the safety and efficacy of its now-approved drug Tavneos, ChemoCentryx has emerged victorious in a securities fraud complaint.

An appeals court overturned a…

August 18th, 2025|Fierce Pharma|

An appeals court overturned a prior FDA action in a years-long face-off between Vanda and the agency over a delayed hearing for Vanda's jet lag disorder hopeful Hetlioz.

Several months after unveiling its…

August 18th, 2025|Fierce Pharma|

Several months after unveiling its direct-to-consumer NovoCare Pharmacy service with the launch of a $499 cash-pay option for a monthly supply of Wegovy, Novo Nordisk is expanding the discount to its other GLP-1 heavyweight.

Sarepta Therapeutics has provided…

August 18th, 2025|Fierce Pharma|

Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy patient group petitions the FDA to update the medicine’s label.