An effort two decades in the making, Vertex Pharmaceuticals Inc.’s suzetrigine gained U.S. FDA approval as the first drug targeting the NaV1.8 pain signal. Branded Journavx, the oral small molecule is ...

In what represents the first PCT filing emerging in the name of Ayble Health Inc., protection is sought for a system for adaptive, multi-level processing of health data to be used in the ...

A week after the first IPO of the year was priced, obesity treatment developer Metsera Inc. and renal specialist Maze Therapeutics Inc. have begun trading on Nasdaq. Metsera (NASDAQ:MTSR) surged 47% ...

A new guidance by the International Medical Device Regulators Forum for good machine learning practices draws heavily on a 2021 playbook provided by Canada, the U.K. and the U.S., an outcome that also ...

A recent study published in Nature Communications by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) and collaborators evaluated a replicating RNA (repRNA) vaccine ...

Harmonized regulations for laboratory-developed tests (LDTs) across Asia Pacific are sorely needed at a time when LDTs continue to play a critical role in addressing unmet needs in the region, ...

Glucocorticoid-induced osteoporosis, the leading cause of secondary osteoporosis, is characterized by diminished bone density and compromised osteoblast function. As current treatment options often ...

Complete response letter hurdles overcome and U.S. FDA clearance in hand, Axsome Therapeutics Inc. will disclose pricing in about four months, closer to the launch of Symbravo to treat adult migraine ...

Now that Novo Nordisk A/S’ blockbuster semaglutide franchise has been selected as one drug for the next round of the CMS price negotiation, the Bagsværd, Denmark-based company is asking a U.S.

EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to ...

Biopharma nonprofit deals remained low in 2024, compared to the pandemic and pre-pandemic years, while grants saw a slight decline from the previous year.

Shanghai Qilu Pharmaceutical Research and Development Centre Ltd. has described histone acetyltransferase KAT6A (monocytic leukemia zinc finger protein; MOZ; MYST-3) and/or KAT6B (MOZ2; MYST-4) ...