Endocrinology — Therapeutic Area Intelligence | Humanexa Signals

StrategyAugust 6, 2026

FDA Grants Approval for Hydrocortisone Sodium Succinate by Zydus Pharmaceuticals

The FDA has granted approval for the ANDA217191 application for Hydrocortisone Sodium Succinate submitted by Zydus Pharmaceuticals.

RegulatoryAugust 4, 2026

FDA Accepts Supplement for VANTAS (Histrelin Acetate) by Endo Operations

The FDA has accepted a supplemental NDA for VANTAS, which contains the active ingredient histrelin acetate.

RegulatoryAugust 4, 2026

FDA Accepts Supplement for Lupron by AbbVie

The FDA has accepted a supplemental application for Lupron (leuprolide acetate) from AbbVie.

RegulatoryAugust 3, 2026

FDA Grants Approval for Vasopressin Application ANDA212068 by Sandoz

The FDA has granted approval for Sandoz's original application for Vasopressin under ANDA212068.

RegulatoryAugust 3, 2026

FDA Approval Process Update for Vasopressin by Sandoz

The FDA has accepted the application ANDA212069 for Vasopressin submitted by Sandoz, with a standard review priority.

RegulatoryAugust 3, 2026

FDA Accepts Supplement Application for Wegovy (Semaglutide) by Novo

The FDA has accepted a supplemental application for Wegovy (semaglutide) submitted by Novo.

RegulatoryAugust 3, 2026

FDA Accepts Supplement for LEVO-T (Levothyroxine Sodium)

The FDA has accepted a supplemental application for LEVO-T, a levothyroxine sodium product, from CEDIPROF INC.

ClinicalAugust 2, 2026

Cognitive Behavioral Intervention Study for Type 1 Diabetes Launched

A new clinical trial is investigating the impact of a cognitive behavioral intervention on lifestyle and glucose management in adults with type 1 diabetes.

ClinicalAugust 2, 2026

MAR002 Study Initiated for Acromegaly Treatment Evaluation

A clinical trial has been initiated to evaluate the safety and tolerability of MAR002 administered subcutaneously in patients with acromegaly.

RegulatoryAugust 1, 2026

FDA Accepts Supplement for NGENLA (BLA761184) from Pfizer

The FDA has accepted a supplemental application for NGENLA (BLA761184) from Pfizer, indicating progress in the regulatory process.

ClinicalAugust 1, 2026

Study on Bone Loss in Anorexia Nervosa Patients to Assess Bone Density and Hormonal Factors

A clinical trial is underway to evaluate bone mineral density and hormonal factors in patients with anorexia nervosa.

RegulatoryJuly 31, 2026

FDA Approval Process Update for Prednisolone ANDA219509

The FDA is currently processing the ANDA219509 application for Prednisolone submitted by TP ANDA Holdings.

ClinicalJuly 30, 2026

Study Evaluates Insulin Infusion Methods for Glycemic Variability in ICU Patients

The study compares two insulin infusion methods to determine which better controls glycemic variability in ICU patients.

RegulatoryJuly 30, 2026

FDA Accepts Supplemental NDA for REZDIFFRA (Resmetirom) by Madrigal

The FDA has accepted a supplemental NDA for REZDIFFRA, indicating progress in its regulatory pathway.

RegulatoryJuly 29, 2026

FDA Accepts Supplemental NDA for Rezdiffra (Resmetirom) by Madrigal

The FDA has accepted a supplemental NDA for Rezdiffra, indicating ongoing development and potential market entry.

RegulatoryJuly 29, 2026

FDA Accepts Supplemental NDA for MACRILEN by Aeterna Zentaris

The FDA has accepted a supplemental NDA for MACRILEN (macimorelin acetate) from Aeterna Zentaris.

ClinicalJuly 29, 2026

Trial Protocol for Hypertonic Glucose vs Insulin-Dextrose in Hyperkalaemia Management

A double-blind randomized controlled trial is being conducted to compare hypertonic glucose and insulin-dextrose for preventing hypoglycaemia in hyperkalaemia treatment.

RegulatoryJuly 29, 2026

FDA Accepts Supplement Application for CRYSVITA (BLA761068)

The FDA has accepted a supplemental application for CRYSVITA (BLA761068) submitted by Kyowa Kirin.

ClinicalJuly 28, 2026

Natural History Study of Excess Androgen in Genetic Conditions

A study is underway to evaluate patients with genetic causes of excess androgen, focusing on conditions like CAH and FMPP.

ClinicalJuly 27, 2026

Gilead's GS-4571 Study Targets Safety and Pharmacokinetics in T2DM and Obesity

Gilead Sciences is conducting a clinical study to evaluate the safety and pharmacokinetics of GS-4571 in various participant groups, including those with Type 2 Diabetes Mellitus.

ClinicalJuly 27, 2026

Ketoconazole Trial for Mild Autonomous Cortisol Secretion Shows Potential to Lower Cortisol Levels

A clinical trial is underway to evaluate the effects of ketoconazole on cortisol levels in patients with mild autonomous cortisol secretion (MACS).

ClinicalJuly 27, 2026

Telemedicine Pilot Study to Enhance Diabetes Self-Management in Emerging Adults

A pilot study is testing a telemedicine approach to improve diabetes self-management education for emerging adults with type 1 diabetes.

ClinicalJuly 27, 2026

Laser Acupuncture Trial for Improving Body Shape in Women with Type 2 Diabetes

A clinical trial is assessing the effectiveness of laser acupuncture on body shape and health in women with uncontrolled Type 2 Diabetes.

ClinicalJuly 26, 2026

Study Aims to Improve Diagnosis and Treatment of Pheochromocytoma

A clinical trial is underway to enhance diagnostic methods and treatment options for pheochromocytoma, a challenging tumor to detect.

CompetitiveJuly 25, 2026

Alveus Therapeutics initiates ALV-100 study for obesity and Type 2 Diabetes

Alveus Therapeutics is conducting a study to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of ALV-100 in overweight/obese participants, including those with Type 2 Diabetes.

StrategyJuly 25, 2026

Fresenius Kabi USA receives AP status for Dexamethasone Sodium Phosphate ANDA209192

Fresenius Kabi USA's ANDA209192 for Dexamethasone Sodium Phosphate has received Abbreviated Approval (AP) status.

CompetitiveJuly 24, 2026

Lilly's retatrutide shows significant weight loss in Phase 3 obesity trials

In Phase 3 trials TRIUMPH-2 and TRIUMPH-3, retatrutide demonstrated significant weight loss in adults with obesity and type 2 diabetes, and severe obesity with cardiovascular disease.

ClinicalJuly 23, 2026

Immunovant's IMVT-1402 Enters Phase 2b for Graves' Disease Treatment

Immunovant Sciences is conducting Phase 2b trial of IMVT-1402 for adults with Graves' disease unresponsive to antithyroid drugs.

ClinicalJuly 23, 2026

Trial to Assess Recruitment Methods for Type 1 Diabetes Screening

A clinical trial is evaluating the effectiveness of different recruitment communication methods for type 1 diabetes screening.

RegulatoryJuly 22, 2026

FDA Accepts ANDA for Vasopressin in Dextrose 5% by Dr. Reddy's

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Vasopressin in Dextrose 5% submitted by Dr.

ClinicalJuly 22, 2026

Endoscopic duodenal therapy shows promise for early Type 2 DM treatment

A study is evaluating the efficacy and safety of endoscopic duodenal re-cellularization therapy for early treatment of Type 2 DM.

RegulatoryJuly 22, 2026

FDA Accepts Supplement for SAXENDA (Liraglutide) by Novo

The FDA has accepted a supplemental application for SAXENDA, an obesity treatment containing liraglutide.

ClinicalJuly 22, 2026

Study on Ethnic Differences in Adipose Tissue Dysfunction and Type 2 Diabetes Risk

A pilot study investigates ethnic differences in adipose tissue dysfunction and its role in insulin resistance and T2D.

RegulatoryJuly 21, 2026

FDA Accepts Supplement Application for Afrezza by MannKind

The FDA has accepted a supplemental application for Afrezza, an inhaled insulin product by MannKind.

ClinicalJuly 20, 2026

Study on Probiotics and Prebiotics for Obesity in Prader-Willi Syndrome Children

A clinical trial is investigating the use of probiotics and prebiotics to manage obesity in children with Prader-Willi syndrome.

CompetitiveJuly 20, 2026

GI Windows, Inc. Initiates Study on Duodenum to Ileal Diversion for Type 2 Diabetes

A clinical trial is underway to evaluate the efficacy of duodenum to ileal diversion in treating Type 2 Diabetes by monitoring HbA1c changes.

ClinicalJuly 20, 2026

Amgen's MARITIME-2-EXTENSION Trial Evaluates Maridebart Cafraglutide for Obesity and Type 2 Diabetes

Amgen is conducting an extension trial to assess the long-term efficacy, safety, and tolerability of maridebart cafraglutide in patients with obesity and type 2 diabetes.

CompetitiveJuly 20, 2026

Crinetics Pharmaceuticals initiates pediatric CAH study for atumelnant

Crinetics Pharmaceuticals is conducting a study to evaluate atumelnant in pediatric patients with classic CAH.

ClinicalJuly 20, 2026

Hoffmann-La Roche Evaluates Petrelintide and Enicepatide in Obesity Trial

A dose-finding study is underway to assess the safety and efficacy of petrelintide combined with enicepatide in adults with obesity.

StrategyJuly 19, 2026

FDA Grants Approval for Levothyroxine Sodium ANDA216370 by Alembic

The FDA has granted approval for Alembic's ANDA216370 for Levothyroxine Sodium.

ClinicalJuly 19, 2026

Phase III Study of DA-302168S for Overweight/Obesity Initiated in China

A Phase III clinical trial for DA-302168S has been initiated to evaluate its efficacy and safety in overweight or obese participants.

RegulatoryJuly 18, 2026

FDA Grants Approval for Enlicitide by Merck Sharp and Dohme

The FDA has granted approval for Enlicitide, an original application by Merck Sharp and Dohme.

RegulatoryJuly 18, 2026

FDA Accepts Supplemental NDA for Desmopressin Acetate by Ferring Pharmaceuticals

The FDA has accepted a supplemental NDA for Desmopressin Acetate submitted by Ferring Pharmaceuticals.

RegulatoryJuly 18, 2026

FDA Accepts Supplement Application for SEROSTIM by EMD Serono

The FDA has accepted a supplemental application for SEROSTIM, an injectable somatropin product.

RegulatoryJuly 18, 2026

FDA Approves BAXFENDY (BAXDROSTAT) by AstraZeneca

The FDA has approved BAXFENDY (BAXDROSTAT) under NDA219878, indicating a significant milestone for AstraZeneca.

StrategyJuly 17, 2026

FDA Grants AP Status for Levothyroxine Sodium ANDA211417

The FDA has granted approval status (AP) for ANDA211417, a generic formulation of Levothyroxine Sodium by Macleods Pharmaceuticals.

RegulatoryJuly 14, 2026

FDA Grants Approval for Estradiol ANDA218214 by Encube

The FDA has granted approval for ANDA218214, a generic estradiol product submitted by Encube.

RegulatoryJuly 14, 2026

FDA Grants Approval for Hydrocortisone Sodium Succinate by Zydus Pharms

The FDA has granted approval for the ANDA217191 application for Hydrocortisone Sodium Succinate submitted by Zydus Pharms.

ClinicalJuly 13, 2026

Study Aims to Improve Diagnosis of Primary Aldosteronism Using LC-MS/MS

A study is underway to establish a new diagnostic cutoff for primary aldosteronism using LC-MS/MS.

RegulatoryJuly 13, 2026

FDA Accepts Supplemental Application for Lupron by AbbVie

The FDA has accepted a supplemental application for Lupron, an injectable hormonal therapy.

CompetitiveJuly 13, 2026

Sandoz Receives FDA Approval for Vasopressin ANDA212069

Sandoz has received an Abbreviated New Drug Application (ANDA) approval for Vasopressin.

StrategyJuly 13, 2026

Sandoz Receives FDA Approval for Vasopressin ANDA212068

Sandoz's ANDA212068 for Vasopressin has received an Abbreviated Approval from the FDA.

RegulatoryJuly 13, 2026

FDA Accepts Supplemental NDA for VANTAS by Endo Operations

The FDA has accepted a supplemental NDA for VANTAS, which contains the active ingredient histrelin acetate.

ClinicalJuly 12, 2026

Pilot Study on Continuous Glucose Monitoring for Postpartum Screening Initiated

A pilot study is being conducted to evaluate continuous glucose monitoring as an alternative to the oral glucose tolerance test for postpartum glucose screening.

RegulatoryJuly 12, 2026

FDA Accepts Supplemental Application for LEVO-T by CEDIPROF INC.

The FDA has accepted a supplemental application for LEVO-T, a levothyroxine sodium product, from CEDIPROF INC.

ClinicalJuly 11, 2026

Impact of PCOM on Hormonal Response to GnRH in Functional Hypothalamic Amenorrhea

The study investigates the hormonal response to pulsatile GnRH therapy in women with functional hypothalamic amenorrhea, focusing on those with and without polycystic ovarian morphology.

ClinicalJuly 10, 2026

Optimizing Estradiol Levels for Menopausal Health: Implications for Hormone Therapy

The study identifies optimal estradiol serum levels that alleviate vasomotor symptoms while also assessing impacts on osteoporosis and cardiovascular health.

ClinicalJuly 10, 2026

Study on Reproductive Axis Maturation in Post-Menarchal Girls and PCOS Risk

A study is investigating menstrual cycle development in girls post-menarch, focusing on those at risk for PCOS.

ClinicalJuly 9, 2026

NIDDK Launches Genetic Study on Insulin Resistance and Diabetes

The NIDDK is conducting a genetic study to explore insulin resistance and diabetes by comparing affected patients to healthy individuals.

RegulatoryJuly 9, 2026

FDA Approves Supplemental Application for Levothyroxine Sodium by Fresenius Kabi

The FDA has approved a supplemental application for Levothyroxine Sodium submitted by Fresenius Kabi.

ClinicalJuly 9, 2026

Ascendis Pharma's ACP-001 Shows Promise in Weekly Growth Hormone Therapy for GHD

A six-month study is comparing the safety and efficacy of ACP-001, a long-acting growth hormone, to daily hGH in children with GHD.

StrategyJuly 9, 2026

Sandoz Receives FDA Approval for Liraglutide ANDA212972

Sandoz has received an Abbreviated New Drug Application (ANDA) approval for Liraglutide.

ClinicalJuly 9, 2026

Lumos Pharma initiates Phase 3 extension study for LUM-201 in pediatric growth hormone deficiency

Lumos Pharma is conducting Phase 3 long-term safety extension study for LUM-201 in children with growth hormone deficiency.

ClinicalJuly 9, 2026

Pilot Trial on Mindfulness-Based Diabetes Education for Rural Black Adults

A pilot randomized controlled trial will compare mindfulness-based education with standard diabetes education in rural Black adults.

RegulatoryJuly 9, 2026

FDA Accepts Supplement for PARLODEL by Esjay Pharma

The FDA has accepted a supplemental application for PARLODEL (bromocriptine mesylate) from Esjay Pharma.

StrategyJuly 8, 2026

FDA Grants Approval for Prednisone ANDA218035 by Dr. Reddy's

The FDA has granted approval for Dr. Reddy's Abbreviated New Drug Application for Prednisone.

RegulatoryJuly 8, 2026

FDA Accepts Supplemental Application for NGENLA (Somatrogon-GHLA)

The FDA has accepted a supplemental application for NGENLA, a growth hormone therapy developed by Pfizer.

RegulatoryJuly 7, 2026

FDA Grants AP Status for Prednisolone ANDA219509 by TP ANDA Holdings

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Prednisolone submitted by TP ANDA Holdings.

ClinicalJuly 7, 2026

AstraZeneca's Phase III Trial of Baxdrostat in Primary Aldosteronism Underway

AstraZeneca is conducting Phase III trial to evaluate the efficacy and safety of baxdrostat in patients with Primary Aldosteronism.

ClinicalJuly 6, 2026

Type 2 Diabetes Remission in Gynecologic Oncology Patients Post-Weight Loss Protocol

The study reviews T2D remission and glycaemic improvement in gynecologic oncology patients with class 3 obesity after a preoperative weight loss protocol.

CompetitiveJuly 6, 2026

Early Feasibility Study of UniBE Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes

The UBLoop-Genesis study is evaluating a novel hybrid closed-loop insulin delivery system for Type 1 diabetes.

RegulatoryJuly 5, 2026

FDA Accepts Supplement Application for CRYSVITA (BUROSUMAB-TWZA)

The FDA has accepted a supplemental application for CRYSVITA (BUROSUMAB-TWZA) from Kyowa Kirin.

ClinicalJuly 4, 2026

MyDiaMate Study Aims to Alleviate Diabetes Distress in Type 1 Diabetes

The MyREMEDY study evaluates the effectiveness of the MyDiaMate app in improving mental health for adults with type 1 diabetes.

ClinicalJuly 4, 2026

Study Links Age and Mortality in Men with Testosterone Deficiency and Impact of Therapy

The study reveals that testosterone therapy alters the relationship between age and mortality in men with adult-onset testosterone deficiency.

ClinicalJuly 3, 2026

Study on Quercetin's Impact on Glucose Absorption in Obesity and Type 2 Diabetes

A clinical trial is investigating the effects of quercetin on glucose absorption in obese individuals and those with type 2 diabetes.

ClinicalJuly 3, 2026

Phase 1b/2a Trial of CNP-103 for Stage 3 Type 1 Diabetes Initiated

COUR Pharmaceutical has initiated Phase 1b/2a clinical trial for CNP-103 in adolescents and adults with recently diagnosed Stage 3 Type 1 Diabetes.

ClinicalJune 30, 2026

Biohaven's BHV-1300 Trial for Graves' Disease Underway

Biohaven Therapeutics is conducting a trial to assess the efficacy and safety of BHV-1300 in adults with Graves' disease.

RegulatoryJune 30, 2026

FDA Drug Trials Snapshot for PALSONIFY in Acromegaly

PALSONIFY is indicated for adults with acromegaly who have not responded adequately to surgery or are not surgical candidates.

CompetitiveJune 30, 2026

Triastek Initiates Phase 1 Trial for Octreotide Acetate Tablets (T25) Bioavailability

Triastek is conducting Phase 1 trial to evaluate the bioavailability of T25 compared to Mycapssa and the food effect on pharmacokinetics.

ClinicalJune 29, 2026

Novo Nordisk Tests UBT251 for Type 2 Diabetes in New Clinical Trial

Novo Nordisk is conducting a clinical trial to evaluate the efficacy and safety of UBT251 in patients with type 2 diabetes.

ClinicalJune 28, 2026

Pilot study compares transdermal and oral HRT effects on bone density in Turner syndrome

The study evaluates the impact of oral versus transdermal hormone replacement therapy on bone mineral density in women with Turner syndrome.

RegulatoryJune 27, 2026

FDA Accepts Supplement for ADRENALIN (Epinephrine) NDA204640

The FDA has accepted a supplemental application for ADRENALIN, which contains epinephrine as the active ingredient.

RegulatoryJune 26, 2026

FDA Grants Priority Review for ZEGALOGUE Supplemental Application

The FDA has granted priority review status for the supplemental application of ZEGALOGUE (dasiglucagon hydrochloride) submitted by Zealand Pharma.

ClinicalJune 26, 2026

Digital Health Tools Show Promise in Accelerating Lifestyle Habit Formation for Diabetes Risk

A randomized controlled trial is assessing the effectiveness of a digital intervention in accelerating healthy habit formation in adults at risk for Type 2 Diabetes.

ClinicalJune 26, 2026

AstraZeneca's Elecoglipron Phase III Trials Target Obesity and T2DM

AstraZeneca is conducting two pivotal Phase III studies to evaluate the efficacy and safety of elecoglipron in adults with obesity or overweight, with and without T2DM.

ClinicalJune 25, 2026

Eli Lilly's Eloralintide Trial Targets Insulin Sensitivity in Obesity

Eli Lilly is conducting a 35-week trial to evaluate eloralintide's effects on insulin sensitivity and metabolic health in overweight or obese participants.

RegulatoryJune 25, 2026

FDA Approves Tryngolza for Reducing Acute Pancreatitis Risk in Severe Hypertriglyceridemia

The FDA has approved Tryngolza (olezarsen) for reducing triglycerides and the risk of acute pancreatitis in adults.

ClinicalJune 25, 2026

Study on Duodenal pulsENDO for Type II Diabetes and Liver Disease Initiated

A clinical trial is underway to assess the efficacy and safety of the pulsENDO procedure in patients with suboptimally controlled Type II Diabetes Mellitus and steatotic liver disease.

ClinicalJune 25, 2026

Long-acting growth hormone shows transient BMI increase in children, raising treatment compliance concerns

Long-acting growth hormone treatments like Somapacitan and Somatrogon show a transient increase in BMI during the first year of treatment in children, with some patients experiencing significant weight gain.

CompetitiveJune 24, 2026

Hoffmann-La Roche's Enicepatide Trial Targets Obesity and Type 2 Diabetes

A clinical study is underway to evaluate enicepatide's efficacy and safety in managing weight for obese or overweight participants with Type 2 diabetes.

ClinicalJune 24, 2026

Study on Carbohydrate Intake Impact in Type 1 Diabetes with Advanced Hybrid Closed-loop System

A study is evaluating the impact of daily carbohydrate intake on glycemic control in youth with type 1 diabetes using an advanced hybrid closed-loop system.

ClinicalJune 23, 2026

Study on Rifampin for CYP24A1-related Hypercalcemia and Hypercalciuria Initiated

A clinical trial is underway to assess the efficacy of rifampin in treating hypercalcemia and hypercalciuria linked to CYP24A1 mutations.

ClinicalJune 23, 2026

Study on Continuous Glucose Monitoring in Gestational Diabetes Outcomes

The study will evaluate how continuous glucose monitoring affects outcomes for mothers and infants in gestational diabetes, considering socioeconomic and cultural factors.

RegulatoryJune 23, 2026

FDA Accepts Supplement for Paricalcitol by Hikma Pharmaceuticals

The FDA has accepted a supplemental application for Paricalcitol submitted by Hikma Pharmaceuticals.

StrategyJune 23, 2026

FDA Grants Approval for Cabergoline ANDA220309 by Renata

The FDA has granted approval for ANDA220309, a generic version of cabergoline submitted by Renata.

StrategyJune 23, 2026

FDA Grants Approval for Mylan's Liraglutide ANDA213155

The FDA has granted approval for Mylan's Abbreviated New Drug Application (ANDA) for Liraglutide.

RegulatoryJune 22, 2026

FDA Approves Tzield for Pediatric Stage 3 Type I Diabetes

The FDA has approved Tzield (teplizumab) for delaying insulin loss in pediatric patients with Stage 3 Type I diabetes.

ClinicalJune 22, 2026

Study on Urinary Alkalinization's Impact on Uric Acid in Type 1 Diabetes

A study is investigating the effect of sodium bicarbonate on urine uric acid crystallization in adults with type 1 diabetes.

ClinicalJune 21, 2026

Study on Exercise Programs for Women with PCOS Initiated by Biruni University

A clinical trial is underway to assess the effectiveness of a digital rehabilitation-supported exercise program in women with PCOS.

ClinicalJune 21, 2026

Study on Sleep Regularity's Impact on Glycemic Control in Type 1 Diabetes

A mechanistic study will explore how improving sleep regularity affects glycemic control and cardiovascular risk in individuals with type 1 diabetes.

ClinicalJune 21, 2026

Dulce Digital 2.0 Study Aims to Enhance Diabetes Self-Management via Digital Tools

The Dulce Digital 2.0 study will evaluate two mHealth adaptations aimed at improving digital health literacy and self-management in underserved diabetes populations.

RegulatoryJune 21, 2026

FDA Approves Supplement for Estradiol by Mylan Technologies

The FDA has approved a supplemental application for estradiol submitted by Mylan Technologies.

ClinicalJune 21, 2026

Clinical Trial on Anti-inflammatory Diet's Impact on Type 2 Diabetes Management

A randomized controlled trial is evaluating the effects of an anti-inflammatory dietary intervention on inflammation and glycemic control in patients with type 2 diabetes.

ClinicalJune 20, 2026

Genetic Variants ERBB4 and SHBG Linked to PCOS Risk in South Indian Women

The study investigates the association of ERBB4 and SHBG gene polymorphisms with the risk of polycystic ovary syndrome in South Indian women.

ClinicalJune 20, 2026

Eli Lilly's Orforglipron Study in Adolescents with Obesity Underway

Eli Lilly is conducting a study to evaluate the efficacy and safety of orforglipron in adolescents with obesity or related comorbidities.

ClinicalJune 19, 2026

Edinburgh Study Investigates Pancreas Lipotoxicity and Weight Loss in Type 2 Diabetes

The Edinburgh Diabetes Remission Study aims to explore the role of fat accumulation in the pancreas and its impact on type 2 diabetes remission through weight loss.

RegulatoryJune 18, 2026

FDA Accepts Application for BAXFENDY (BAXDROSTAT) from AstraZeneca

The FDA has accepted the New Drug Application for BAXFENDY (BAXDROSTAT) from AstraZeneca.

RegulatoryJune 17, 2026

FDA Proposes Exclusion of Semaglutide, Tirzepatide, and Liraglutide from 503B Bulks List

The FDA has proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, indicating no clinical need for compounding these drugs.

RegulatoryJune 16, 2026

FDA Approves Tzield for Pediatric Patients with Stage 3 Type 1 Diabetes

The FDA granted accelerated approval for Tzield (teplizumab) to delay insulin production decline in pediatric patients with Stage 3 T1D.

ClinicalJune 16, 2026

Roche to Present Phase II Data on Enicepatide and Petrelintide at ADA 2026

Roche will present new Phase II data for enicepatide and petrelintide in obesity at the ADA Scientific Sessions.

StrategyJune 16, 2026

Lilly's Foundayo Shows Significant Weight Loss in Menopausal Women

In clinical trials, Foundayo demonstrated significant weight loss in women across all stages of menopause, with losses up to 30.4 lbs.

CompetitiveJune 16, 2026

Lilly's Foundayo shows superior results in Phase 3 trial for type 2 diabetes

Phase 3 ACHIEVE results indicate Foundayo outperformed oral semaglutide and dapagliflozin in treating type 2 diabetes.

ClinicalJune 13, 2026

Phase II Trial of SAL0140 Shows Promise for Primary Aldosteronism

A Phase II clinical trial is underway to evaluate the efficacy and safety of SAL0140 at varying doses in patients with primary aldosteronism.

ClinicalJune 10, 2026

AI-Driven Nutrition Study for Type 2 Diabetes Shows Promise for Glycemic Control

The AIM-MET study is evaluating a microbiome-targeted nutritional product's effect on glycemic control in type 2 diabetes over 24 weeks.

Companies

Assets

Recent signals(114)

FDA Grants Approval for Hydrocortisone Sodium Succinate by Zydus Pharmaceuticals

FDA Accepts Supplement for VANTAS (Histrelin Acetate) by Endo Operations

FDA Accepts Supplement for Lupron by AbbVie

FDA Grants Approval for Vasopressin Application ANDA212068 by Sandoz

FDA Approval Process Update for Vasopressin by Sandoz

FDA Accepts Supplement Application for Wegovy (Semaglutide) by Novo

FDA Accepts Supplement for LEVO-T (Levothyroxine Sodium)

Cognitive Behavioral Intervention Study for Type 1 Diabetes Launched

MAR002 Study Initiated for Acromegaly Treatment Evaluation

FDA Accepts Supplement for NGENLA (BLA761184) from Pfizer

Study on Bone Loss in Anorexia Nervosa Patients to Assess Bone Density and Hormonal Factors

FDA Approval Process Update for Prednisolone ANDA219509

Study Evaluates Insulin Infusion Methods for Glycemic Variability in ICU Patients

FDA Accepts Supplemental NDA for REZDIFFRA (Resmetirom) by Madrigal

FDA Accepts Supplemental NDA for Rezdiffra (Resmetirom) by Madrigal

FDA Accepts Supplemental NDA for MACRILEN by Aeterna Zentaris

Trial Protocol for Hypertonic Glucose vs Insulin-Dextrose in Hyperkalaemia Management

FDA Accepts Supplement Application for CRYSVITA (BLA761068)

Natural History Study of Excess Androgen in Genetic Conditions

Gilead's GS-4571 Study Targets Safety and Pharmacokinetics in T2DM and Obesity

Ketoconazole Trial for Mild Autonomous Cortisol Secretion Shows Potential to Lower Cortisol Levels

Telemedicine Pilot Study to Enhance Diabetes Self-Management in Emerging Adults

Laser Acupuncture Trial for Improving Body Shape in Women with Type 2 Diabetes

Study Aims to Improve Diagnosis and Treatment of Pheochromocytoma

Alveus Therapeutics initiates ALV-100 study for obesity and Type 2 Diabetes

Fresenius Kabi USA receives AP status for Dexamethasone Sodium Phosphate ANDA209192

Lilly's retatrutide shows significant weight loss in Phase 3 obesity trials

Immunovant's IMVT-1402 Enters Phase 2b for Graves' Disease Treatment

Trial to Assess Recruitment Methods for Type 1 Diabetes Screening

FDA Accepts ANDA for Vasopressin in Dextrose 5% by Dr. Reddy's

Endoscopic duodenal therapy shows promise for early Type 2 DM treatment

FDA Accepts Supplement for SAXENDA (Liraglutide) by Novo

Study on Ethnic Differences in Adipose Tissue Dysfunction and Type 2 Diabetes Risk

FDA Accepts Supplement Application for Afrezza by MannKind

Study on Probiotics and Prebiotics for Obesity in Prader-Willi Syndrome Children

GI Windows, Inc. Initiates Study on Duodenum to Ileal Diversion for Type 2 Diabetes

Amgen's MARITIME-2-EXTENSION Trial Evaluates Maridebart Cafraglutide for Obesity and Type 2 Diabetes

Crinetics Pharmaceuticals initiates pediatric CAH study for atumelnant

Hoffmann-La Roche Evaluates Petrelintide and Enicepatide in Obesity Trial

FDA Grants Approval for Levothyroxine Sodium ANDA216370 by Alembic

Phase III Study of DA-302168S for Overweight/Obesity Initiated in China

FDA Grants Approval for Enlicitide by Merck Sharp and Dohme

FDA Accepts Supplemental NDA for Desmopressin Acetate by Ferring Pharmaceuticals

FDA Accepts Supplement Application for SEROSTIM by EMD Serono

FDA Approves BAXFENDY (BAXDROSTAT) by AstraZeneca

FDA Grants AP Status for Levothyroxine Sodium ANDA211417

FDA Grants Approval for Estradiol ANDA218214 by Encube

FDA Grants Approval for Hydrocortisone Sodium Succinate by Zydus Pharms

Study Aims to Improve Diagnosis of Primary Aldosteronism Using LC-MS/MS

FDA Accepts Supplemental Application for Lupron by AbbVie

Sandoz Receives FDA Approval for Vasopressin ANDA212069

Sandoz Receives FDA Approval for Vasopressin ANDA212068

FDA Accepts Supplemental NDA for VANTAS by Endo Operations

Pilot Study on Continuous Glucose Monitoring for Postpartum Screening Initiated

FDA Accepts Supplemental Application for LEVO-T by CEDIPROF INC.

Impact of PCOM on Hormonal Response to GnRH in Functional Hypothalamic Amenorrhea

Optimizing Estradiol Levels for Menopausal Health: Implications for Hormone Therapy

Study on Reproductive Axis Maturation in Post-Menarchal Girls and PCOS Risk

NIDDK Launches Genetic Study on Insulin Resistance and Diabetes

FDA Approves Supplemental Application for Levothyroxine Sodium by Fresenius Kabi

Ascendis Pharma's ACP-001 Shows Promise in Weekly Growth Hormone Therapy for GHD

Sandoz Receives FDA Approval for Liraglutide ANDA212972

Lumos Pharma initiates Phase 3 extension study for LUM-201 in pediatric growth hormone deficiency

Pilot Trial on Mindfulness-Based Diabetes Education for Rural Black Adults

FDA Accepts Supplement for PARLODEL by Esjay Pharma

FDA Grants Approval for Prednisone ANDA218035 by Dr. Reddy's

FDA Accepts Supplemental Application for NGENLA (Somatrogon-GHLA)

FDA Grants AP Status for Prednisolone ANDA219509 by TP ANDA Holdings

AstraZeneca's Phase III Trial of Baxdrostat in Primary Aldosteronism Underway

Type 2 Diabetes Remission in Gynecologic Oncology Patients Post-Weight Loss Protocol

Early Feasibility Study of UniBE Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes

FDA Accepts Supplement Application for CRYSVITA (BUROSUMAB-TWZA)

MyDiaMate Study Aims to Alleviate Diabetes Distress in Type 1 Diabetes

Study Links Age and Mortality in Men with Testosterone Deficiency and Impact of Therapy

Study on Quercetin's Impact on Glucose Absorption in Obesity and Type 2 Diabetes

Phase 1b/2a Trial of CNP-103 for Stage 3 Type 1 Diabetes Initiated

Biohaven's BHV-1300 Trial for Graves' Disease Underway