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FDA approves bemotrizinol for over-the-counter sunscreen use – first new active ingredient since 1999
The FDA approved bemotrizinol as the first new sunscreen ingredient for over-the-counter consumer use in the US since 1999, giving US shoppers a new UV-filter option that has been used for decades...
European Medicines Agency moves to revoke Amgen’s Tavneos – data integrity becomes central issue
The EMA recommended withdrawing marketing authorization for Amgen’s Tavneos (avacopan) after concluding that data underpinning the original approval were “incorrect and misleading” and could no...
FDA advisory panels return under new oversight – Replimune and Capricor hearings set to test leadership shift
FDA advisory committee meetings are back on the calendar under new leadership, with renewed emphasis on panels for contested product applications. Two announced meetings—covering Replimune and...
US regulatory and policy pressure on China-biotech dealmaking – House committee to vote on investment and in-licensing restrictions
A House committee is set to vote on proposals that would tighten China investment and in-licensing restrictions, including adding BINSA-research restrictions and domestic biomanufacturing support...
Replimune presses for third FDA attempt on RP1 melanoma – decision date set for Aug. 2
The FDA accepted Replimune’s regulatory resubmission for RP1, its oncolytic immunotherapy in advanced melanoma, setting an expected decision on or before Aug. 2. The agency also plans an advisory...
Viridian’s veligrotug approved in thyroid eye disease – intensifying competition with Tepezza
The FDA approved Viridian Therapeutics’ thyroid eye disease drug veligrotug, to be marketed as Lumvoa, according to the report. The approval starts a new competitive chapter for the condition,...
Natera hit with class action over allegedly misleading PGT-A marketing – Spectrum test discontinued before filing
Natera is facing a class action lawsuit in the Northern District of California alleging false and misleading marketing of its preimplantation genetic testing for aneuploidy, Spectrum PGT-A....
Bionyra Pharma launches from stealth with $165M Series A to build next-gen inflammatory disease biologics
Bionyra Pharma emerged from stealth after raising $165 million in an oversubscribed Series A to develop next-generation biologics for severe immunological and inflammatory diseases. The funding...
Weill Cornell and Roswell Park advance intravesical MUC16 CAR-T – preclinical bladder tumor control in mice
Researchers at Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center reported preclinical results showing that intravesical delivery of MUC16-targeting CAR T cells can control...
Emerging diagnostics: BioMérieux submits rapid multiplex vaginitis PCR panel to FDA for dual 510(k)/CLIA waiver
BioMérieux submitted a rapid multiplex PCR vaginitis panel to the FDA, seeking dual 510(k) clearance and a CLIA waiver for point-of-care use. The assay, BioFire SpotFire Vaginitis Panel (VG), is...
Regulatory action – Tavneos integrity concerns (EU and FDA alignment)
European regulators moved to withdraw Tavneos in a formal escalation of the drug’s data-integrity controversy. The EMA’s CHMP recommended revoking marketing authorization after it said it could...
FDA advisory panels return – contested oncology and cellular therapy reviews
FDA advisory panels are set to resume with fresh meetings tied to previously contested applications. Under new leadership, the agency indicated it would place renewed emphasis on advisory meetings...
Clinical validation – intravesical CAR T approach targets MUC16 in bladder cancer
Weill Cornell Medicine and Roswell Park reported preclinical evidence that directly delivering CAR T cells into the bladder can control bladder tumors. In a Journal of Experimental Medicine study,...
Funding – Bionyra Pharma launches with $165M Series A for inflammatory disease biologics
Bionyra Pharma emerged from stealth after raising $165 million in an oversubscribed Series A to develop next-generation biologics for severe inflammatory and immune-driven diseases. The new...
Regulatory and reimbursement – US FDA submits rapid vaginitis PCR for dual 510(k)/CLIA waiver
BioMérieux filed with the FDA seeking clearance and CLIA waiver for a rapid multiplex PCR vaginitis panel designed to return results in about 20 minutes at the point of care. The submission covers...
Therapy pipeline – Otsuka’s centanafadine hits endpoint in ADHD with comorbid anxiety Phase IIIb
Otsuka reported a clinical win for centanafadine in patients with ADHD and comorbid anxiety. Top-line results from a dedicated Phase IIIb study met the primary endpoint, defined as symptom score...
Transactions – Boundless Bio merges into Serapha Bio in $230M deal
Boundless Bio agreed to merge with Serapha Bio in an all-stock transaction valued at $230 million, consolidating the combined entity under the Serapha Bio name. After completion, the company is...
Policy and politics – House committee to vote on China investment and in-licensing restrictions
A House committee is scheduled to vote on proposals that would tighten China-related investment and in-licensing restrictions for US biomedical activity. The package would consider additions such...
Platform science – AI human-in-the-loop framework proposes GPNMB CAR T target in solid tumors
Researchers used an AI human-in-the-loop framework to nominate CAR T targets and reported preclinical activity for a GPNMB-directed construct across multiple cancer models. In a Cell paper, a...
Research integrity – Nature Medicine retracts China-led immunotherapy-before-3-p.m. lung cancer study
Nature Medicine retracted a high-profile Chinese lung cancer paper that claimed immunotherapy timing—before 3 p.m.—could dramatically improve survival. The journal cited unresolved concerns about...