Travere claims first FDA OK in rare kidney disease FSGS
Pharmaphorum
Shrugging off an earlier phase 3 disappointment, Travere’s Filspari has become the first FDA-approved treatment for rare kidney disease FSGS.
Novo Nordisk and OpenAI forge alliance to drive speedy drug development
Pharmaceutical Technology
Novo Nordisk inks this deal with OpenAI as the total value of AI partnerships took a 120% YoY uptick between 2024 and 2025.
Revolution rockets on strong pancreatic cancer data
Pharmaphorum
Revolution Medicines thinks it could transform the treatment of pancreatic cancer based on phase 3 data with its pan-RAS(on) inhibitor daraxonrasib.
MSD, Daiichi Sankyo’s ifinatamab deruxtecan receives FDA priority
Pharmaceutical Technology
MSD and Daiichi Sankyo have received priority review from the FDA for ifinatamab deruxtecan’s BLA to treat ES-SCLC.
Alamar, Hemab, Kailera, and Seaport advance IPOs
Pharmaphorum
The last few days have seen a flurry of biotech IPO news, with Alamar, Hemab, Kailera, and Seaport all pushing for Nasdaq listings.
Spyre drug for inflammatory bowel disease shows promise in early study
BioPharma Dive
The therapy, which works similarly to Takeda s blockbuster Entyvio, showed remission rates that suggest a best-in-class profile, the company said.
Allogene data suggest ‘off-the-shelf’ CAR-T could delay relapse in lymphoma
BioPharma Dive
Initial results from a high-stakes trial indicate the biotech may have finally found a niche in lymphoma care for a donor-derived cell therapy.
USP adds Tamiflu, Trulicity to vulnerable list as upstream analysis reshapes supply concerns
BioSpace
Almost half of the top 100 medicines vulnerable to supply disruptions in the U.S.
Allogene stock sails after CAR T clears residual lymphoma in early data cut
BioSpace
Pivotal findings for the off-the-shelf cell therapy surpassed William Blair’s expectations and sent Allogene Therapeutics’ stock up more than 50% in pre-market trading Monday morning.
220: An Interview With Dr. Jaime Moore on Obesity Medications and Neuromuscular Disease
Rare Disease Audio
Larry Luxner, senior correspondent for Rare Disease Advisor, interviews Jaime Moore, MD, about weight loss drugs–specifically the role of GLP-1 receptor agonists in treating children with neuromuscula
Revolution rises 40% as pancreatic cancer drug doubles survival
BioSpace
In a difficult disease, Revolution Medicines achieved what the pancreatic cancer community has long desired: a significant improvement in survival.
IDEAYA and Servier’s eye cancer drug heads to FDA after delivering ‘best in class’ efficacy
BioSpace
Darovasertib, in combination with crizotinib, more than doubled progression-free survival in a registrational trial, leading Truist analysts to declare a “best-in-class efficacy profile” for the PKC i
IDEAYA/Servier PKC drug aces uveal melanoma trial
Pharmaphorum
Servier $210m bet on IDEAYA’s uveal melanoma therapy darovasertib seems to have paid off, as a trial sets up regulatory filings later in 2026.
AbbVie enters world of pain in up to $715M deal with China’s Haisco
BioSpace
The licensing deal marks AbbVie’s first foray into new pain medicines, a space where Vertex currently enjoys a lead thanks to the NaV1.8 inhibitor Journavx.
AbbVie bets on Chinese biopharma’s pain pipeline in $745m bid
Pharmaceutical Technology
AbbVie’s deal with Haisco comes as many pharma companies look to restock their pipelines amid looming global patent expiries.
FDA issues complete response letter to Replimune’s RP1 for melanoma
Pharmaceutical Business Review
The decision affects Replimune’s lead product candidate, which is based on a genetically engineered herpes simplex virus intended to stimulate an anti-tumour immune response.
Data backs GSK’s ovarian cancer blockbuster hopes
Pharmaphorum
GSK’s B7-H4-targeting ADC Mo-Rez chalks up impressive results in ovarian and endometrial cancer, prompting a major phase 3 trials programme.
FDA issues complete response letter to Replimune’s RP1 for melanoma
Pharmaceutical Technology
The FDA has issued a complete response letter to Replimune’s biologics license application concerning the RP1 therapy.
FDA hands another rejection to Replimune’s melanoma therapy
Pharmaphorum
Replimune has had its advanced melanoma treatment RP1 turned down by the FDA for a second time, prompting job losses.