It marks the first of seven peptide drugs the FDA's Pharmacy Compounding Advisory Committee will address on Thursday and Friday.

Roche’s Vabysmo disappointed investors again. In the second quarter, the eye drug’s sales of about 1.04 billion Swiss francs ($1.27 billion) missed analysts’ expectations by 7.1%. | On an investor ...

Johnson & Johnson has unveiled massive phase 3 survival data for its dual bispecific combination in earlier-line multiple myeloma, delivering another catalyst that could add a new twist in the ...

In a landmark moment for its oncology ambitions, GSK has secured FDA approval for Jideytro (zidesamtinib) as the first commercial lung cancer drug in the company’s history. The milestone was made ...

The FDA has called out Sanofi’s promotion of respiratory syncytial virus (RSV) antibody Beyfortus in a new untitled letter, taking issue with the company’s characterization of the med as a general | ...

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.  In ...

A U.K. marketing watchdog has reprimanded Sanofi for using “a highly misleading interpretation of data” to make disparaging claims about Pfizer’s respiratory syncytial virus (RSV) vaccine.

Less than a month after Ionis Pharmaceuticals scored an FDA expansion for Tryngolza to become the first drug to specifically treat severe hypertriglyceridemia (sHTG), Arrowhead Pharmaceuticals has ...

Amgen has agreed to a $74 million settlement with investors who allege that the company hid a massive U.S. tax bill from the public. | Amgen has agreed to a $74 million settlement with investors to ...

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, though not for the sorts of ...

Detailed phase 3 results suggest the two-drug combination of Gilead Sciences’ lenacapavir and Merck & Co.’s islatravir has what it takes to become the first complete weekly pill for the treatment of ...

Novartis' CEO remains unfazed by the threat of a newly approved oral PCSK9 inhibitor in Merck & Co.’s Lipfendra, doubling down on the long-term potential of his company's injectable cholesterol drug, ...