Category: Regulatory
PharmaSignal — Regulatory
FDA delays decision on Sanofi’s subcutaneous Sarclisa
Pharmaphorum
The FDA has extended its review of a new version of Sanofi’s multiple myeloma Sarclisa that could help narrow the gap with arch-rival Darzalex.
Health Canada approves Biocon’s two denosumab biosimilars
Pharmaceutical Technology
Biocon has received a Notice of Compliance from Health Canada for Bosaya and Vevzuo, both biosimilars referencing Prolia and Xgeva, respectively.
Novo Nordisk preps filings for sickle cell drug etavopivat
Pharmaphorum
Novo Nordisk has claimed a key win in its head-to-head race with Agios to bring an oral PKR activator to the market for sickle cell disease.
FDA kicks off review of Roche’s Gazyva for wider lupus use
Pharmaphorum
Roche could be just months away from an FDA approval of Gazyva as the first anti-CD20 therapy for systemic lupus erythematosus.
Pfizer and Astellas secure FDA priority review for Padcev MIBC combo therapy
Pharmaceutical Business Review
The application aims to allow the use of this combination therapy for all patients with MIBC, regardless of their cisplatin eligibility.
Pfizer and Astellas secure FDA priority review for Padcev MIBC combo therapy
Pharmaceutical Technology
Pfizer and Astellas have received FDA acceptance for priority review of their sBLA for perioperative Padcev combined with Keytruda for MIBC.
MSD secures EC approval for Enflonsia to prevent infant RSV infection
Pharmaceutical Business Review
This approval authorises Enflonsia’s marketing across all 27 European Union member states, Iceland, Liechtenstein and Norway.
Replimune cries foul on regulatory flexibility. But many Americans want a stricter FDA
BioSpace
After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack
FDA moves toward easing restrictions on certain peptides
BioPharma Dive
The agency s decision to hold an advisory committee meeting on the topic comes after HHS Secretary Robert F.
Travere wins long-awaited approval for kidney disease drug
BioPharma Dive
The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity believed to be worth more than $1 billion annually.
FDA Approves Extended Dosing Interval for Regeneron’s EYLEA HD (aflibercept)
Big Molecule Watch
On April 2, 2026, Regeneron Pharmaceuticals announced that the U.S.
Lilly’s new obesity pill linked to ‘serious’ safety signals, FDA requests more data
BioSpace
The FDA is asking Eli Lilly to submit cardiovascular and liver safety data from an ongoing Phase 3 trial of Foundayo by July.
FDA renews criticism of trial sponsors over transparency
Pharmaphorum
The FDA has launched a drive to get clinical trial sponsors to disclose the results of studies – even if they are negative.
Travere Therapeutics gains FDA approval for sparsentan in FSGS
Pharmaceutical Business Review
The approval makes Filspari the first and only FDA-approved medicine to treat FSGS, expanding its use beyond IgA nephropathy (IgAN) into a second rare kidney condition.
Travere Therapeutics gains FDA approval for sparsentan in FSGS
Pharmaceutical Technology
Travere Therapeutics has received FDA approval for Filspari to reduce proteinuria in patients aged eight years and over with FSGS without nephrotic syndrome.
MSD, Daiichi Sankyo’s ifinatamab deruxtecan receives FDA priority
Pharmaceutical Business Review
The treatment targets adult patients with ES-SCLC who have experienced disease progression on or after platinum-based chemotherapy.
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.
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.
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