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Regulatory withdrawal for Tavneos in Europe
European regulators moved to pull Amgen’s Tavneos from the market, citing that evidence submitted for the original approval could no longer be relied upon. The EMA committee recommended withdrawal...
FDA advisory committee reset for contested melanoma submission
Replimune secured a new timeline for its twice-rejected melanoma therapy RP1 after the FDA accepted the company’s resubmission and set an advisory committee meeting in late July. The agency is...
Sequencing genomics retraction undermines China lung cancer claim
Nature Medicine retracted a widely publicized Chinese lung cancer study, “Lungtime-C01,” after concerns intensified about research integrity and data transparency. The paper had reported that...
Global pharma deals and U.S.-China licensing tightening at BIO
At BIO 2026, U.S. biotech leaders debated how far Congress should go in restricting licensing deals tied to Chinese biotech, amid rising alarm in the industry. Lawmakers signaled interest in...
U.S. policy pressure on China biotech investment and trial acceptance
A new bill before Congress would amend the COINS Act to extend additional licensing restrictions to Chinese biotechnology, according to the piece. The proposal would also include mechanisms that...
Capital infusion for inflammation biologics startup Bionyra
Bionyra Pharma emerged from stealth after raising an oversubscribed $165 million Series A to build next-generation biologics for severe inflammatory and immune-driven diseases. The financing was...
New FDA approval expands sunscreen actives to U.S. OTC
The FDA approved bemotrizinol as the first new sunscreen ingredient permitted for over-the-counter consumer use in the U.S. since 1999. The action allows an ingredient already used in other...
Corporate tie-up: Circio and Tcelltech combine for non-viral in vivo T-cell engineering
Circio and Tcelltech agreed to combine technologies to develop next-generation in vivo CAR-T and TCR-T cells using non-viral DNA delivery. The collaboration pairs Circio’s circVec circular RNA...
Regenerative medicine and diagnostics funding via ARPA-H fetal monitoring grants
ARPA-H committed $90.7 million over four years under its Making Obstetrics Care Smart (MOCS) program to fund diagnostic tests and fetal monitoring technologies aimed at reducing risks during...
Debt and equity financing activity: Adaptive Biotechnologies convertible notes
Adaptive Biotechnologies issued $345 million of zero-interest convertible senior notes due in 2031, with proceeds used in part to refinance and reduce earlier leverage. The financing included an...
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...