Michael Rivera MS, Biotechnology

Adial Pharmaceuticals Completes Azora Merger, Expands Ulcerative Colitis Pipeline

Adial Pharmaceuticals completed its acquisition of Azora Therapeutics on June 11, 2026, and SEC filings show related equity issuance to Azora holders. The filings also show new RSUs and stock options granted to Adial’s CDO.

Weight Loss Medications in 2026: GLP-1 Market Shift

Palvella Therapeutics Begins Phase 2 Trial of QTORIN Rapamycin for Rare Angiokeratomas

Palvella Therapeutics doses first patients in Phase 2 LOTU trial of QTORIN rapamycin for angiokeratomas, targeting over 50,000 US patients with no approved treatments.

FDA Approves Guardant360 CDx Companion Diagnostic for Pfizer's VEPPANU in ER+/HER2- Breast Cancer

Guardant Health receives FDA approval for blood-based companion diagnostic to identify patients eligible for VEPPANU treatment in advanced breast cancer with ESR1 mutations.

InflaRx Reports Favorable Safety Profile for Izicopan in Liver Metabolism Study

InflaRx announces positive pre-clinical data showing low reactive metabolite formation for izicopan in human liver microsomes, supporting drug safety profile.

ZETA SURGICAL Receives FDA 510(k) Clearance for Brain Surgery Navigation System

ZETA SURGICAL's Zeta Navigation System receives FDA 510(k) clearance for brain tumor biopsies, hydrocephalus treatment, and trigeminal neuralgia procedures.

Arvinas Receives FDA Approval for VEPPANU (Vepdegestrant), First PROTAC Drug for ESR1-Mutated Breast Cancer

Arvinas announces FDA approval of VEPPANU, the first PROTAC protein degrader for ESR1-mutated, ER+/HER2- advanced breast cancer treatment.

FDA Places Clinical Hold on Newron's Evenamide Phase III Trial for Treatment-Resistant Schizophrenia

FDA halts enrollment in Newron's Phase III ENIGMA-TRS 2 study of evenamide for treatment-resistant schizophrenia, creating regulatory uncertainty for the novel therapy.

Tempest Therapeutics TPST-2003 CAR-T Shows Promise for Multiple Myeloma at ISCT 2026

Tempest Therapeutics presents positive TPST-2003 dual-targeting CAR-T data for relapsed/refractory multiple myeloma patients at ISCT 2026 meeting.

Aclaris Therapeutics ATI-052 Shows Promising 45-Day Half-Life in Phase 1a Trial Results

Aclaris Therapeutics announces positive Phase 1a results for ATI-052, a first-in-class anti-TSLP/IL-4Rα bispecific antibody with 45-day half-life for Th2 diseases.

C-Ray Therapeutics Receives FDA Acceptance for Copper-64 Drug Master File, Advancing Radiopharmaceutical Development

C-Ray Therapeutics' Copper-64 Drug Master File receives FDA acceptance, enabling global radiopharmaceutical developers to reference DMF No. 43568 for submissions.

AbbVie Submits FDA Application for Upadacitinib (RINVOQ) to Treat Severe Alopecia Areata

AbbVie submits FDA application for upadacitinib (RINVOQ) to treat severe alopecia areata in adults and adolescents, backed by Phase 3 trial data.

Novartis Reports Strong Q1 2026 Growth Led by Remibrutinib CHMP Approval and Pipeline Advances

Novartis delivers strong Q1 2026 growth with Remibrutinib receiving positive CHMP opinion for chronic spontaneous urticaria and multiple pipeline milestones.

DMX-200 ACTION3 Trial Maintains Statistical Power Above 90% Following Blinded Data Review

External statistical review confirms DMX-200's ACTION3 trial remains >90% powered to demonstrate proteinuria reduction in kidney disease patients.

FDA Grants Priority Review for IMAAVY (Nipocalimab-aahu) as First Potential Treatment for Warm Autoimmune Hemolytic Anemia

FDA grants Priority Review for IMAAVY (nipocalimab-aahu), potentially the first approved treatment for warm autoimmune hemolytic anemia (wAIHA).

Merck Mayo Clinic AI Partnership: Advancing Drug Discovery

Merck and the Mayo Clinic have joined forces to leverage AI in accelerating drug discovery and development. This partnership combines Merck's expertise with Mayo Clinic's research capabilities to transform pharmaceutical innovation.

Sun Pharma Acquires Organon for $11.75 Billion in Major Pharmaceutical Merger

Sun Pharmaceutical Industries announces $11.75 billion acquisition of Organon at $14 per share, creating global pharmaceutical powerhouse.

Boston Scientific FARAPULSE and WATCHMAN Show Positive Safety Data at Heart Rhythm 2026

Boston Scientific presents positive clinical trial data for FARAPULSE Pulsed Field Ablation and WATCHMAN devices at Heart Rhythm 2026 conference.

Veradermics VDPHL01 Phase 2/3 Trial Results for Male Pattern Hair Loss to Be Announced

Veradermics announces investor call to discuss topline results from Phase 2/3 study of VDPHL01 for mild-to-moderate male pattern hair loss treatment.

Veradermics VDPHL01 Phase 2/3 Trial Results: Conference Call Scheduled for Oral Minoxidil Hair Loss Treatment

Veradermics announces investor call to discuss Phase 2/3 trial results for VDPHL01, an extended-release oral minoxidil tablet for male pattern hair loss.

Adagio Medical's vCLAS Ventricular Ablation System Shows 84% Success Rate in Pivotal Trial for Heart Arrhythmia Treatment

Adagio Medical's vCLAS system achieved 84% freedom from shock and 59% freedom from VT recurrence in FULCRUM-VT pivotal trial, meeting primary endpoints.

Aquestive Therapeutics Faces Class Action Lawsuit Over Alleged FDA Application Misrepresentations

Aquestive Therapeutics investors who purchased AQST stock between June 2025 and January 2026 face May 4 deadline to join class action lawsuit over alleged FDA misstatements.

Medtronic Affera Sphere-9 Catheter Receives FDA Breakthrough Device Designation for Ventricular Tachycardia Treatment

Medtronic's Sphere-9 catheter gains FDA breakthrough status for VT treatment while Sphere-360 shows consistent durability across patient anatomies in new clinical data.

Haemonetics VASCADE MVP XL Shows Superior Safety Profile in Large-Bore Venous Closure Study

New study demonstrates Haemonetics' VASCADE MVP XL vascular closure system's enhanced safety and efficacy in large-bore venous access procedures.