FDA Drug Approvals & Clinical Trials

GL

globenewswire

Priovant Announces FDA Acceptance and Priority Review of New Drug Application for Brepocitinib in Dermatomyositis

Globenewswire 03 Mar 2026 EN

DURHAM, N.C., March 03, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for brepocitinib for the treatment of dermatomyositis (DM) and has granted the application Priority Review. The FDA has assigned a Prescription Drug User Fee Act...

ME

menafn

Complicated Urinary Tract Infection Market: Accelerating Growth And Pipeline Impact By 2034 Delveinsight Allecra Therapeutics, Merck Sharp & Dohme, Abbvie, Shionogi, Melinta Therapeutics, Spero

Menafn 03 Mar 2026 EN

(MENAFN - GetNews) The Key Complicated Urinary Tract Infection Companies in the market include - Allecra Therapeutics, Merck Sharp & Dohme, AbbVie, Shionogi, Melinta Therapeutics, Spero ...

OP

openpr

Healthcare Regulatory Affairs Outsourcing Market Forecast 2026-2036: Market to Reach USD 4.56 Billion by 2036 at 6.7% CAGR

Openpr 03 Mar 2026 EN

NEWARK, DE | The healthcare regulatory affairs outsourcing market was valued at USD 2.3 billion in 2025 and is projected to rise to USD 2.45 billion in 2026. According to Future Market Insights, the market is expected to reach USD

OP

openpr

Chronic Venous Insufficiency Market Insights Highlight Expanding Outlook Till 2034, DelveInsight Evaluates

Openpr 02 Mar 2026 EN

DelveInsight's "Chronic Venous Insufficiency Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Chronic Venous Insufficiency, historical and forecasted epidemiology as well as the Chronic Venous Insufficiency market trends in the United States, EU4 (Germany, Spain,

OP

openpr

Systemic Lupus Erythematosus Market: Rapid Increment Driven by Innovation by 2034- DelveInsight

Openpr 02 Mar 2026 EN

DelveInsight's "Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Systemic Lupus Erythematosus, historical and forecasted epidemiology as well as the Systemic Lupus Erythematosus market trends in the United States, EU5 (Germany, Spain,

ME

medcitynews

Theravance Drug Fails Another Pivotal Test, This Time Sparking Restructuring That Ends R&D

Medcitynews 03 Mar 2026 EN

Ampreloxetine’s Phase 3 failure in multiple system atrophy is the third disappointing clinical trial outcome for the Theravance Biopharma drug. The biotech will now wind down all R&D and explore options that could include the sale of the company. The post Theravance Drug Fails Another Pivotal Test, This Time Sparking Restructuring That Ends R&D...

CI

cision

CalciMedica Reports 2025 Financial Results and Provides Clinical Updates

Cision 03 Mar 2026 EN

Internal and external reviews of all available safety data from the Phase 2 KOURAGE trial in acute kidney injury (AKI) did not identify evidence of a drug-related toxicity with AuxoraTM Design of pivotal program in acute pancreatitis (AP) expected in 1H 2026 JCI Insight publication of...

PH

pharmaphorum

Clinical Trials Round-Up – Jan to Feb 2026

Pharmaphorum 03 Mar 2026 EN

Clinical Trials Round-Up – Jan to Feb 2026Nicole.RaleighTue, 03/03/2026 - 16:18

PH

pharmaphorum

Ascendis scores FDA approval for weekly dwarfism drug

Pharmaphorum 03 Mar 2026 EN

Ascendis scores FDA approval for weekly dwarfism drugPhil.TaylorTue, 03/03/2026 - 11:55

TH

the_tob

CEVIRA Approved in China as First-in-Class Non-Invasive Therapy for Cervical Precancerous Lesions

The_tob 03 Mar 2026 EN

OSLO, Norway, March 3, 2026 /PRNewswire/ — Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that its core product APL-1702 (trade name: CEVIRA®), has received the Drug Registration Certificate from China’s National Medical Products Administration (NMPA),...