The U.S. FDA announced Dec. 15 that it will take a more relaxed approach regarding the use of real-world evidence (RWE) in drug and device application reviews. Specifically, new guidance for device premarket applications will not require identifiable individual patient data collected from real-world data sources, and the agency indicated it intends to consider similarly updating guidance regarding submissions for drugs and biologics.

Pharvaris NV looks to start filing marketing applications in the first half of 2026 on the back of positive phase III data showing oral bradykinin B2 receptor antagonist deucrictibant hit all primary and secondary endpoints as an on-demand treatment for hereditary angioedema (HAE) attacks.

Q32 Bio Inc. handed off rights to phase II-stage complement inhibitor ADX-097 in a deal with Akebia Therapeutics Inc. that helps the former extend its cash runway to focus on lead candidate bempikibart in alopecia areata and bolsters the latter’s efforts to build a rare kidney disease pipeline.

Detailed data will be forthcoming at a scientific congress, but Bayer AG’s positive top-line readout from its phase III study testing oral factor XIa (FXIa) inhibitor asundexian in reducing the risk of ischemic stroke offered a much-needed win for the FXIa space, which encountered its latest stumble just over a week ago.

“Our goal is that by the end of this call, you’ll share our conviction in the totality of the data.” So said Agios Pharmaceuticals Inc. CEO Brian Goff as the company reported top-line data from its 52-week Rise Up trial testing mitapivat in sickle cell disease showing the oral pyruvate kinase activator hit statistical significance on one of two primary endpoints and two of three key secondary endpoints.

Arrowhead Pharmaceuticals Inc. won U.S. FDA approval of plozasiran in familial chylomicronemia syndrome (FCS), the second drug to gain clearance for use in the rare genetic disease following the late 2024 nod for Ionis Pharmaceuticals Inc.’s Tryngolza (olezarsen), setting up a battle in the marketplace even as the firms wage a patent dispute regarding the two RNA-based therapies.

Pfizer Inc. emerged over the weekend as the winner of the bidding war for Metsera Inc., with the two reaching an amended agreement after market close Nov. 7 that values the obesity drugmaker at about $10 billion. The next day, the other contender, Novo Nordisk A/S, confirmed it does not intend to increase its most recent offer.

Centessa Pharmaceuticals plc’s unremarkable third-quarter 2025 earnings report was greatly overshadowed by an early readout from its orexin receptor 2 (OX2R) agonist program in narcolepsy, particularly promising phase IIa data demonstrating ORX-750’s efficacy across a group of sleep disorders, though investors seek further data to differentiate Centessa’s program from potential competitors such as Takeda Pharmaceutical Co. Ltd.’s oveporexton and Alkermes plc’s alixorexton.

Only two days after Bridgebio Pharma Inc. impressed investors with data from BBP-418 in limb-girdle muscular dystrophy type 2I/R9, the company was back at it again, this time reporting positive top-line results from its global phase III study of encaleret in autosomal dominant hypocalcemia type 1, a genetic form of hypoparathyroidism.