Aurobindo's manufacturing operations have once again landed the Indian drugmaker in hot water with the U.S. FDA. | ...

Ever since President Donald Trump nominated Robert F. Kennedy Jr. | In a Friday speech to FDA employees, the HHS secretary ...

Originally approved by the FDA in 1998, Amgen’s Enbrel is still sailing along without facing biosimilar competition in the ...

Despite President Donald Trump’s threat last week that tariffs on pharmaceuticals will come “very shortly,” the biopharma ...

If you ever find yourself doing outdoor hobbies in slow motion or bursting into a full-blown musical theater scene at the ...

Gilead Sciences’ sponsorship of a conference Wi-Fi network has landed it in hot water. | Gilead Sciences’ sponsorship of a ...

The HIV-focused biopharma has received its latest bid from CDMO Future Pak for a cool $255 million, but the drugmaker had to ...

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

Already thriving with a successful launch of infused Vyvgart and its subcutaneous follow-on Vyvgart Hytrulo to the tune of $2 ...

Bristol Myers Squibb has received the FDA’s green light to introduce another immunotherapy-based treatment in first-line ...

Nearly a year after winning an accelerated approval for its DLL3-targeting small cell lung cancer (SCLC) therapy Imdelltra, ...

Despite the challenges, including what CSL CEO Paul McKenzie has described as a fragmented U.S. healthcare system, the blood ...