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BioWorld - Sunday, May 3, 2026
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Atrial fibrillation illustration
Heart Rhythm 2026

Med-tech companies highlight PFA data as competition intensifies

April 27, 2026
By Shani Alexander
No Comments
New data on pulsed field ablation (PFA) presented at Heart Rhythm 2026 in Chicago over the weekend continue to show the benefits and superiority of the technologies in treating patients with atrial fibrillation. The PFA landscape is fast-evolving and med-tech players are jostling for market share with ever-differentiated platforms looking to attract electrophysiologists.
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Illustration of cancer in the bile ducts

S-OS? Compass phase II/III biliary data mixed; ahoy, FDA

April 27, 2026
By Randy Osborne
No Comments
Having already hit the primary endpoint of overall response rate in the phase II/III Companion-002 study testing the bispecific antibody tovecimig in biliary tract cancer, Compass Therapeutics Inc. rolled out new data from the same experiment and plans to meet with the U.S. FDA to discuss a BLA. Shares of the Boston-based firm (NASDAQ:CMPX) closed April 27 at $1.79, down about 64%, or $3.23, as Wall Street sifted the results.
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Male hair loss

MANE event: Veradermics beats expectations in pattern hair loss trial

April 27, 2026
By Jennifer Boggs
No Comments
Shares of Veradermics Inc. spiked as the first top-line readout from its registrational program for VDPHL-01 showed the oral, extended-release version of minoxidil surpassed expectations in men with mild to moderate pattern hair loss, setting up commercial aspirations as a potential best-in-indication treatment option.
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Drug R&D concept image.
Newco news

Anaptysbio’s spinout First Tracks hits the slopes

April 24, 2026
By Brian Orelli
No Comments
Anaptysbio Inc. announced in September of 2025 that it planned to separate its drug development business from the royalties it receives on Jemperli (dostarlimab) from GSK plc and imsidolimab from Vanda Pharmaceuticals Inc. Just seven months later, on April 20, 2026, well ahead of its “year-end 2026” goal, First Tracks Biotherapeutics Inc., the drug development arm of the company, started trading as a standalone company on Nasdaq under the ticker symbol TRAX.
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Edwards Lifesciences Sapien M3

Edwards raises 2026 guidance on strong TAVR performance

April 24, 2026
By Shani Alexander
No Comments
Edwards Lifesciences Corp. raised its full-year 2026 guidance after seeing strong sales in the first quarter, particulalry from its transcatheter aortic valve replacement (TAVR) business. The company now expects sales growth of 9% to 11%, up from prior outlook of 8% to 10%, and adjusted earnings per share of $2.95 to $3.05, compared with earlier guidance of $2.90 to $3.05.
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Epileptic brain and abnormal EEG wave discharges

Neuro deals aplenty: UCB’s $1B+ takeover of Neurona the latest

April 24, 2026
By Karen Carey
No Comments
A flurry of deals focused on the neurological disease space in 2026 suggest large biopharma companies are searching for the next best therapeutics for everything from epilepsy and narcolepsy to post-traumatic stress disorder and hyperphagia.
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Cerebral aneurysm illustration

Grace Therapeutics hits CRL setback with GTx-104 despite positive trial

April 24, 2026
By Tamra Sami
No Comments
Grace Therapeutics Inc.’s hopes of becoming the first company in decades to update the standard of care in aneurysmal subarachnoid hemorrhage were delayed after the U.S. FDA issued a complete response letter (CRL) for its GTx-104 NDA, citing manufacturing and nonclinical deficiencies rather than concerns over efficacy or safety.
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Citizen petition asks for clarity in CRL disclosures

April 23, 2026
No Comments
The U.S. FDA’s recent pledge to make public complete response letters (CRLs) for drugs and biologics that failed to gain approval has encountered some objections from industry regarding the potential for disclosure of trade secrets and proprietary information.
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CMS logo and website

FDA, CMS partner to deliver RAPIDly for innovative devices

April 23, 2026
By Mari Serebrov
No Comments
The U.S. FDA and CMS are teaming up to give Medicare beneficiaries quicker access to breakthrough medical devices and provide manufacturers with certainty of reimbursement.
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Dupixent

Dupi whoopie: Sanofi/Regeneron cheered for sales, new approval

April 23, 2026
By Randy Osborne
No Comments
As Sanofi SA gets ready to welcome a new CEO, the company along with partner Regeneron Pharmaceuticals Inc. said a happy hello as well to robust sales of Dupixent (dupilumab, dupi) and gained U.S. FDA clearance for the IL-4 receptor alpha antagonist to treat children, ages 2 to 11, with chronic spontaneous urticaria who remain symptomatic despite histamine-1 antihistamine treatment.
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