Industry News
Pharmaceutical Industry News
Generic drugmakers will face…
Generic drugmakers will face import tariffs in the U.S., President Donald Trump announced this week. Samsung Biologics is pursuing the biggest M&A deal ever for a Korean biopharma company. In an unconventional move, a U.S.
An FDA advisory committee has…
An FDA advisory committee has recommended that four peptide drugs that were previously restricted because of potential safety concerns be restored to the 503A Bulk Drug Substances list, which would remove the limits on how
On an investor call Thursday,…
On an investor call Thursday, Roche Pharmaceuticals CEO Teresa Graham assured analysts that the U.S. branded market has stabilized after a period of contraction, though the explosive growth that Vabysmo enjoyed early in its launch
As the recent reshoring zeal rolls…
As the recent reshoring zeal rolls on in the United States, BeOne Medicines is beefing up its flagship manufacturing and R&D campus in New Jersey to the tune of $300 million.
A Peptide Showdown: F.D.A. Scientists May Clash With R.F.K.’s Agenda
Agency scientists are advising against allowing widespread use of several peptide injections. Robert F. Kennedy Jr., the health secretary, has said people should be free to experiment.
The FDA slammed a pair of…
The FDA slammed a pair of India-based API manufacturers in separate warning letters outlining poor record-keeping, problems maintaining sanitation and licensing issues, among other observations.
The former quarterback spoke with…
The former quarterback spoke with Fierce Pharma Marketing on teaming up with ARS, his journey with food allergies and why needle-free epinephrine Neffy is an "incredible option."
In a landmark moment for its…
In a landmark moment for its oncology ambitions, GSK has secured FDA approval for Jideytro as the first commercial lung cancer drug in the company’s history. The milestone was made possible by GSK’s recent acquisition
Directors Andrew Goldstein and…
Directors Andrew Goldstein and Valerie Bowling discuss what to expect at the 2026 PODD: Partnership Opportunities in Drug Delivery conference.
Trump’s New Trade Fights (and Deals)
President Trump has resumed his approach of big threats against some trading partners and generous pacts with others. Experts see new risks.
The FDA’s Office of Prescription…
The FDA's Office of Prescription Drug Promotion took issue with Sanofi's characterization of antibody Beyfortus as an RSV preventative, as the med is specifically indicated for RSV lower respiratory tract disease.
Less than a month after Ionis…
Less than a month after Ionis scored an FDA expansion for Tryngolza to become the first drug to specifically treat severe hypertriglyceridemia, Arrowhead has countered with head-turning data from two phase 3 trials that could
While the White House focused its…
While the White House focused its initial Section 232 pharmaceutical tariffs on branded drugs, generics makers—who supply the vast majority of U.S. prescriptions—won’t stay in the clear for long.
Aiming to bolster ivonescimab’s…
Aiming to bolster ivonescimab’s case ahead of a key FDA decision, Summit Therapeutics has provided updated overall survival data from the phase 3 HARMONi trial for its PD-1xVEGF bispecific antibody.
Traditional CSOs prioritize speed…
Traditional CSOs prioritize speed and low costs over candidate fit. Discover why a talent-first approach is rewriting the launch playbook.
Trump Plans to Impose Tariffs on Generic Drugs
The administration has repeatedly said it will impose steep pharmaceutical tariffs but has not followed through on them.
Amgen has agreed to a $74 million…
Amgen has agreed to a $74 million settlement with investors to resolve a lawsuit that alleged the company hid a $10.7 billion tax bill from the public and kept the company's share price artificially high
EVERSANA INTOUCH’s CEO explains…
EVERSANA INTOUCH’s CEO explains why the convergence of AI, creativity and commercialization is becoming the industry's next competitive advantage, transforming outputs into measurable outcomes.
With former Merck KGaA CEO Belén…
With former Merck KGaA CEO Belén Garijo, M.D., Ph.D., now calling the shots at Sanofi, the French drugmaker continues to refine its executive roster, albeit with fewer high-profile C-suite departures now than earlier in the
Following an inspection earlier…
Following an inspection earlier this year that yielded a Form 483, Indian generics juggernaut Alembic Pharmaceuticals has received a harsher reprimand from the U.S. FDA.