Trending
Scientists turn pig semen extract into eye drops that kill cancer in mice
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Sustained nitric oxide production by engineered E. coli remodels the tumor microenvironment and potentiates immunotherapy
Optical Pooled CRISPR Screen Reveals Regulators of NF-κB Dynamics in Human Cells
-
Helixgate Featured6 hours ago2026 DIA/FDA Oligonucleotide-Based Therapeutics Conference – 09/23/2026
The FDA and DIA have expressed a willingness to leverage their combined strengths for the joint development of this conference that will incorporate dialogue between regulators...
-
Helixgate Featured7 hours agoPublic Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA) – 09/16/2026
The Food and Drug Administration is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for...
-
Helixgate Featured7 hours agoList of Determinations Including Written Request
In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a...
-
Helixgate Featured9 hours agoRISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations – 09/29/2026
This public workshop, co-convened by Duke Margolis and the FDA Rare Disease Innovation Hub, will explore statistical considerations in the design, conduct, and analysis of clinical...
-
Regulatory Intelligence & Drug Approvals14 hours agoSTAT+: Definium’s LSD therapy eased anxiety in second large trial
The first wave of biotechs is nearing regulatory approval for psychedelic therapies, a class of treatments that appear to exert rapid benefits.
-
Manufacturing, Supply Chain & Infrastructure14 hours agoWith pharmaceutical tariffs looming, guidance on compliance is still lacking
With tariffs on patented pharmaceuticals and input materials set to take effect for all companies on Sept. 29, the lack of clarity about rules […] The...
-
Regulatory Intelligence & Drug Approvals15 hours agoScholar Rock scores long-awaited FDA approval, the first for muscle loss in SMA
The injectable monoclonal antibody is the first to treat muscle atrophy in patients with SMA, according to the FDA.
-
Clinical Trials & Development15 hours agoCorbus posts phase 1 obesity data for drug mechanism that defeated Novo, Sanofi
Corbus Pharmaceuticals’ phase 1b obesity trial has generated evidence that its CB1 inverse agonist may be less prone to the neuropsychiatric side effects that affected Novo...
-
Manufacturing, Supply Chain & Infrastructure16 hours agoGSK makes ‘difficult decision’ to shutter German flu vaccine manufacturing site
GSK is consolidating two of its influenza vaccine manufacturing sites into one, leaving hundreds of jobs at risk.
-
Capital, M&A & Industry Strategy16 hours agoElectra aims for $342M IPO to power inflammatory drug’s push through phase 3
Electra Therapeutics is hoping to raise up to $341.9 million from an IPO in order to power the clinical development of its inflammatory disorder drug, ipsoprubart.
