Amgen Inc.’s head of R&D James Bradner said his firm was “surprised” by the request from the U.S. FDA Jan. 16 to take Tavneos (avacopan) off the market – and the company said no. “We're in discussions ...

ABL Bio Inc. has submitted an IND application to the FDA seeking clearance to begin a phase I trial of ABL-209 (NEOK-002).

China’s State Council updated its Drug Administration Law, and the changes mark a substantive evolution in the country’s drug regulatory framework.

Scientists at Ghent University have created a mouse model that incorporates human versions of the receptors that recognize the fragment crystallizable (Fc) region of immunoglobulin G (IgG), one of the ...

Medtronic plc is continuing to put its money where its mouth is as it plans to exercise its option to acquire Cathworks Ltd. for up to $585 million. The company said last month it was committed to ...

Following on from a successful phase IIa proof-of-mechanism study in myasthenia gravis, NMD Pharma A/S has added clinical data on a second neuromuscular disorder, reporting positive phase IIa results ...

Another data cut from Ultragenyx Pharmaceutical Inc. regarding UX-111 (rebisufligene etisparvovec), an AAV9 gene therapy for type A Sanfilippo syndrome, continued to brighten the picture for the ...

Onchilles Pharma Inc. has obtained IND approval from the FDA for N-17350, enabling initiation of first-in-human studies in patients with advanced solid tumors. The study will enroll patients in the U.

Connecta Therapeutics SL has discovered 3-phenoxy-3-phenylpropanamine derivatives described as potentially useful for the treatment of fragile X and Rett syndrome.

Secretary Robert Kennedy reportedly said he expected Trumprx to probably go live within 10 days. That was Jan. 29, two days before HHS was once again forced to shut down many of its activities due to ...

Work at Alicorn Pharmaceutical Co. Ltd. has led to the synthesis of new sodium channel protein type 10 subunit α (SCN10A; Nav1.8) blockers. They are reported to be useful for the treatment of pain, ...

Metabolic dysfunction-associated steatohepatitis (MASH) involves hepatic steatosis, inflammation, and fibrosis driven in part by hepatic stellate cell (HSC) activation. Dual inhibition of ACLY and ...