Category: Regulatory
PharmaSignal — Regulatory
Telomir seeks FDA approval for Telomir-1 to treat breast cancer
Pharmaceutical Business Review
The IND includes results from completed toxicology, pharmacology, and manufacturing studies necessary for regulatory assessment.
FDA points to liver injury with Amgen’s Tavneos
Pharmaphorum
The FDA has raised the pressure on Amgen to withdraw vasculitis drug Tavneos from the market with a report linking serious side effects to the drug.
Telomir seeks FDA approval for Telomir-1 to treat breast cancer
Pharmaceutical Technology
Telomir Pharmaceuticals has submitted an IND application to the FDA for Telomir-1, its lead candidate targeting advanced and metastatic TNBC.
AZ considers filings for long-acting Strensiq follow-up
Pharmaphorum
AstraZeneca’s long-acting Strensiq follow-up efzimfotase alfa has hit the mark in children with rare disease HPP, but the data in adults is unclear.
S16 Ep40: FDA Approval Insights: Zongertinib for HER2 TKD-Mutated NSCLC: With Julia Rotow, MD; and Martin Dietrich, MD, PhD
OncLive Podcast
In today’s episode, we spoke with Julia Rotow, MD, and Martin Dietrich, MD, PhD.
Biogen Bounces Back With FDA Nod for High-Dose Spinal Muscular Atrophy Drug
BioSpace
The FDA rejected the high-dose regimen of Spinraza in September last year due to manufacturing concerns.
Amgen’s BiTE for lung cancer backed for EU approval
Pharmaphorum
Amgen’s fast-growing bispecific T-cell engager Imdylltra should be cleared as a second-line therapy for small cell lung cancer, said the CHMP.
Accord, Intas, and Bio-Thera File Four IPRs Against Janssen Golimumab Patents
Big Molecule Watch
On March 20, 2026, Accord BioPharma, Inc.
FDA clears Denali drug in ‘clear step’ for rare disease biotechs
BioPharma Dive
The approval of Denali s Hunter syndrome treatment, Avlayah, comes after a series of drug rejections and delays that had led to criticism of the FDA s stance on rare disease therapies.
FDA seeks feedback on voucher program; Study data lift ‘overhang’ on Insmed shares
BioPharma Dive
Industry executives can share their views on the national priority program at a June meeting.
Pfizer, Valneva to seek approval of Lyme disease vaccine despite mixed study results
BioPharma Dive
The partners said the shot produced clinically meaningful efficacy despite missing its main study objective, a finding they blamed on a lower-than-expected rate of infections during the trial.