BrunoSan Biotech Intelligence

🇺🇸 FDA

U.S. Food & Drug Administration

New Drug Applications, Biologics License, IND holds, Complete Response Letters

reg. actions tracked today

🇪🇺 EMA

European Medicines Agency

CHMP opinions, centralized approvals, EPAR database, orphan designations

2,182

entries in BrunoSan DB

🇨🇦 Health Canada

Health Canada DPD

Drug Product Database — full historic approval records, NOC/NOC-c, DIN registry

11,234

DPD entries integrated

🇧🇷 ANVISA

ANVISA Brazil

Brazilian Health Surveillance Agency — RDC resolutions, drug registrations, market authorizations

actions tracked today

EVENT Flash Alert 2026-05-26

AstraZeneca & Daiichi Sankyo's Datroway Approved for Metastatic TNBC

AstraZeneca, Daiichi Sankyo · Datroway (datopotamab deruxtecan)

The FDA approved the TROP2-directed antibody-drug conjugate (ADC) for adult patients with unresectable or metastatic TNBC.

Confidence: 0.90 Read article →

EVENT Flash Alert 2026-05-26

BioMarin's Voxzogo Succeeds in Phase 3 for Hypochondroplasia, Label Expansion Planned

BioMarin · Voxzogo

The drug achieved positive results in a Phase 3 study, exceeding the company's expectations for this form of dwarfism.

Confidence: 0.90 Read article →

EVENT Global Signal 2026-05-26

FDA Approves First-Ever Treatment for Chronic Hepatitis Delta Virus (HDV)

· Hepcludex (bulevirtide-gmod)

The FDA approved Hepcludex injection, the first treatment for chronic HDV in adults with compensated cirrhosis.

Confidence: 0.90 Read article →

EVENT Global Signal 2026-05-26

Merck & Kelun-Biotech Report Positive Phase 3 Data for ADC Candidate

Merck & Co., Kelun-Biotech · sac-TMT (sacituzumab tirumotecan)

The partnered antibody-drug conjugate reported positive results from three separate Phase 3 trials.

Confidence: 0.90 Read article →

EVENT Global Signal 2026-05-26

Phase 1 NSCLC Combination Trial Terminated Early Due to Toxicity

· capmatinib plus trametinib

The study was terminated after all three enrolled patients discontinued therapy due to significant treatment-related adverse events, with no objective responses observed.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-05-25

Eli Lilly's retatrutide demonstrates ~25% weight loss in Phase 3 obesity trial, setting a high bar for efficacy.

Eli Lilly · Retatrutide

Met its primary endpoint for weight loss in a Phase 3 trial, with patients losing approximately a quarter of their body weight.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-25

FDA approves AstraZeneca and Daiichi Sankyo's ADC datopotamab deruxtecan for metastatic TNBC.

AstraZeneca & Daiichi Sankyo · Datopotamab deruxtecan-dlnk

The FDA granted approval for the TROP2-directed antibody-drug conjugate (ADC) for patients with metastatic TNBC.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-05-25

Merck & Kelun-Biotech's ADC sac-TMT meets primary endpoint in Phase 3 first-line TNBC trial.

Merck & Co., Kelun-Biotech · Sacituzumab Tirumotecan (sac-TMT)

The Phase 3 OptiTROP-Breast03 study met its primary endpoint of progression-free survival (PFS) versus chemotherapy.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-25

FDA approves first-ever treatment for Hepatitis Delta Virus, Gilead's Hepcludex.

Gilead Sciences · Hepcludex (bulevirtide-gmod)

The FDA approved Hepcludex injection, making it the first authorized treatment for adults with chronic HDV.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-25

FDA approves Otsuka/Lundbeck's brexpiprazole for agitation in Alzheimer's dementia.

Otsuka & Lundbeck · Brexpiprazole

The FDA approved a new indication for the medication to treat agitation, a common and challenging behavioral symptom of Alzheimer's.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-05-24

Eli Lilly's Retatrutide Sets High Bar with ~25% Weight Loss in Phase 3 Obesity Trial

Eli Lilly · retatrutide

Met its primary endpoint for weight loss in a Phase 3 trial, with patients treated with the drug losing roughly a quarter of their body weight.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-24

FDA Approves Datopotamab Deruxtecan for Metastatic Triple-Negative Breast Cancer

Not Specified · datopotamab deruxtecan-dlnk

The FDA has granted approval for the antibody-drug conjugate (ADC) for patients with metastatic TNBC.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-05-24

Merck & Kelun-Biotech Report Triple Phase 3 Wins for ADC Sac-TMT

Merck & Co., Kelun-Biotech · sacituzumab tirumotecan (sac-TMT)

The OptiTROP-Breast03 Phase 3 study met its primary endpoint of progression-free survival (PFS) as a first-line treatment for advanced TNBC.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-24

FDA Approves New Medication for Agitation in Alzheimer's Dementia

Not Specified · Not Specified

The FDA approved a new medication to treat agitation, a common and challenging behavioral symptom of Alzheimer's disease.

Confidence: 0.90 Read article →

Phase 3 Global Signal 2026-05-24

BioMarin's Voxzogo Succeeds in Phase 3 for Hypochondroplasia, Paving Way for Label Expansion

BioMarin · Voxzogo

The drug achieved positive Phase 3 results in a study for hypochondroplasia, exceeding company expectations and prompting plans to file for a label expansion.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-05-23

Eli Lilly's Retatrutide Achieves ~25% Weight Loss in Phase 3 Obesity Trial

Eli Lilly · retatrutide

The triple-G agonist met its primary endpoint in a Phase 3 trial, with patients losing approximately a quarter of their body weight.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-23

FDA Approves Datopotamab Deruxtecan for Metastatic Triple-Negative Breast Cancer

Not Specified · datopotamab deruxtecan-dlnk

The FDA has approved the antibody-drug conjugate (ADC) for adult patients with unresectable or metastatic TNBC.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-05-23

Merck & Kelun-Biotech's ADC Sac-TMT Reports Positive Results in Three Phase 3 Trials

Merck & Co., Kelun-Biotech · sacituzumab tirumotecan (sac-TMT)

The Phase III study (OptiTROP-Breast03) for first-line advanced TNBC met its primary endpoint of Progression-Free Survival (PFS).

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-23

FDA Approves New Medication for Agitation in Alzheimer's Dementia

Not Specified · Not Specified

The FDA has approved a new medication for treating agitation associated with Alzheimer's dementia, a common and distressing symptom.

Confidence: 0.90 Read article →

Trial Halt Global Signal 2026-05-23

Phase 1 Combination Trial in MET-driven NSCLC Halted Early Due to Toxicity

Not Specified · capmatinib plus trametinib

The study was terminated after all three enrolled patients discontinued therapy due to significant treatment-related adverse events, with no objective responses observed.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-05-22

Eli Lilly's retatrutide shows major weight loss in Phase 3 obesity trial

Eli Lilly · retatrutide

Met its primary endpoint for weight loss, with patients treated with the drug losing roughly a quarter of their body weight.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-05-22

BioMarin's Voxzogo succeeds in Phase 3 for hypochondroplasia, plans label expansion

BioMarin · Voxzogo

Achieved positive Phase 3 results that exceeded company expectations, prompting plans to file for a label expansion.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-22

FDA approves first-in-class drug for hypertension

Not specified · Not specified

The FDA has approved a novel, first-in-class therapy for hypertension.

Confidence: 0.90 Read article →

Phase 3 Global Signal 2026-05-22

Kelun-Biotech's sac-TMT meets primary endpoint in first-line advanced TNBC

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Sacituzumab Tirumotecan (sac-TMT)

The Phase 3 OptiTROP-Breast03 study met its primary endpoint of Progression-Free Survival (PFS) for first-line treatment of advanced TNBC.

Confidence: 0.90 Read article →

Trial Halt Global Signal 2026-05-22

Phase 1 combination therapy trial in MET-driven NSCLC terminated early due to toxicity

Not specified · capmatinib plus trametinib

The study was terminated after all three enrolled patients discontinued therapy due to significant treatment-related adverse events, with no objective responses observed.

Confidence: 0.90 Read article →

EVENT Flash Alert 2026-05-21

AstraZeneca secures FDA approval for first-in-class hypertension drug baxdrostat

AstraZeneca · baxdrostat

FDA approved baxdrostat, an aldosterone synthase inhibitor (ASI), for hypertension following a strong Phase 3 performance.

Confidence: 0.90 Read article →

EVENT Flash Alert 2026-05-21

Alumis halts development of Tepezza rival, explores strategic alternatives

Alumis Inc · Undisclosed drug program

The company has stopped its program intended to compete with Amgen's Tepezza and will not proceed with the planned Phase 3 development.

Confidence: 0.90 Read article →

EVENT Global Signal 2026-05-21

BioMarin's VOXZOGO succeeds in Phase 3 for Hypochondroplasia, but another asset fails

BioMarin · VOXZOGO (vosoritide)

The pivotal study for VOXZOGO met its primary endpoint, showing a statistically significant improvement in annualized growth velocity (AGV) of 2.33 cm/yr compared to placebo. This

Confidence: 0.90 Read article →

EVENT Global Signal 2026-05-21

Enhertu wins FDA approval for two new indications in early HER2-positive breast cancer

Daiichi Sankyo and AstraZeneca · Enhertu (trastuzumab deruxtecan)

The FDA approved the ADC for two new indications in the early-stage setting for HER2-positive breast cancer.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-05-20

BioMarin's rare disease drug fails Phase 3 trial

BioMarin Pharmaceutical · Enzyme replacement therapy

The drug failed to meet its primary goal and showed no clinical benefit in a Phase 3 study for the rare genetic disorder ENPP1 deficiency.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-20

AstraZeneca wins FDA approval for hypertension drug baxdrostat

AstraZeneca · baxdrostat

The FDA approved baxdrostat, a first-in-class aldosterone synthase inhibitor (ASI), for the treatment of hypertension.

Confidence: 0.90 Read article →

Trial Halt Flash Alert 2026-05-20

Alumis halts Phase 3 program for Tepezza rival

Alumis Inc · Undisclosed

The company has halted its drug program, a potential competitor to Amgen's Tepezza, and will not proceed with the planned Phase 3 development.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-20

Enhertu approved for two new indications in early breast cancer

Daiichi Sankyo and AstraZeneca · Enhertu (trastuzumab deruxtecan)

The FDA approved Enhertu for two new indications in HER2-positive early breast cancer, expanding its use to earlier stages of the disease.

Confidence: 0.90 Read article →

Phase 3 Global Signal 2026-05-20

Tebentafusp confirms long-term survival benefit in uveal melanoma

· Tebentafusp

The final 5-year analysis of a Phase 3 trial demonstrated a sustained overall survival benefit for tebentafusp in HLA-A*02:01-positive adult patients with metastatic uveal melanoma

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-19

AstraZeneca secures FDA approval for novel hypertension drug baxdrostat

AstraZeneca · baxdrostat

FDA approved the aldosterone synthase inhibitor (ASI) following an impressive Phase 3 showing.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-05-19

BioMarin's $270M bet on Inozyme's rare disease therapy falters on Phase 3 miss

Inozyme / BioMarin · Enzyme replacement therapy

The therapy met only one of two dual primary endpoints in a Phase 3 study in children.

Confidence: 0.90 Read article →

Trial Halt Flash Alert 2026-05-19

Alumis halts development of Tepezza rival, explores strategic alternatives

Alumis Inc · Undisclosed

The company has halted the program and will not proceed with the planned Phase 3 development.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-19

FDA approves Enhertu for two new indications in early-stage HER2-positive breast cancer

Daiichi Sankyo and AstraZeneca · Enhertu (trastuzumab deruxtecan)

The FDA approved two new indications for the antibody-drug conjugate in the adjuvant setting.

Confidence: 0.90 Read article →

Trial Halt Flash Alert 2026-05-18

Aardvark Therapeutics' Phase 3 Prader-Willi Program Hit with Full FDA Clinical Hold

Aardvark Therapeutics · Unnamed lead candidate

The FDA imposed a full clinical hold on the company's Phase 3 studies, prompting Aardvark to unblind the trial data early.

Confidence: 0.90 Read article →

Trial Halt Flash Alert 2026-05-18

Alumis Halts Development of Amgen Tepezza Rival, Explores Strategic Alternatives

Alumis Inc · Unnamed drug program

The company has halted its drug program, a potential rival to Amgen's Tepezza, and will not proceed with the planned Phase 3 development.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-18

FDA Approves Daiichi Sankyo's Enhertu for Early-Stage HER2+ Breast Cancer

Daiichi Sankyo, Inc. · Enhertu (fam-trastuzumab deruxtecan-nxki)

The FDA granted approval for two separate indications in adults with HER2-positive early-stage breast cancer, including for neoadjuvant treatment.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-18

Roche's Tecentriq Gains FDA Approval for Adjuvant Bladder Cancer with Companion Diagnostic

Roche / Genentech, Inc. · Tecentriq (atezolizumab)

FDA approved Tecentriq as an adjuvant treatment for adults with ctDNA-positive MIBC post-surgery, alongside Natera's Signatera as a companion diagnostic.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-05-18

FDA Approves First Interchangeable Biosimilars to J&J's Simponi

Not Specified · Immgolis (golimumab-sldi)

The FDA approved Immgolis and Immgolis Intri as the first interchangeable biosimilars to Simponi and Simponi Aria, respectively.

Confidence: 0.90 Read article →

EVENT Flash Alert 2026-05-06

Pfizer scraps remaining assets from $2.3B Trillium acquisition, marking a total failure.

Pfizer · CD47 blocker & T-cell engager

Pfizer has abandoned all clinical-stage candidates acquired through its $2.3 billion acquisition of Trillium Therapeutics.

Confidence: 0.90 Read article →

EVENT Flash Alert 2026-05-06

Viridian's Tepezza rival succeeds in second Phase 3 trial, clearing path for FDA filing.

Viridian Therapeutics · Anti-IGF-1R antibody

The drug met its primary endpoint in a second Phase 3 trial, with the company planning an FDA submission next year.

Confidence: 0.90 Read article →

EVENT Global Signal 2026-05-06

Gossamer Bio faces class-action lawsuit after Phase 3 failure leads to 80% stock drop.

Gossamer Bio, Inc. · Seralutinib

The company's stock dropped 80% following the failure of its Phase 3 PROSERA trial, triggering a securities class action lawsuit.

Confidence: 0.90 Read article →

EVENT Global Signal 2026-05-06

IDEAYA's darovasertib combo meets primary endpoint in registrational trial for uveal melanoma.

IDEAYA Biosciences · Darovasertib

The Phase 2/3 OptimUM-02 trial met its primary endpoint, and the company plans to initiate the RTOR submission process with the FDA.

Confidence: 0.90 Read article →

EVENT Global Signal 2026-05-06

Crinetics Pharma secures EMA approval for Palsonify (paltusotine) for acromegaly.

Crinetics Pharmaceuticals Europe GmbH · Palsonify (paltusotine hydrochloride)

The European Medicines Agency (EMA) has granted marketing authorisation for Palsonify, an oral, once-daily treatment for acromegaly.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-04-29

FDA Approves Regeneron's Otarmeni, First-Ever Gene Therapy for Genetic Hearing Loss

Regeneron · Otarmeni (lunsotogene parvec-cwha)

The FDA approved Otarmeni, the first dual adeno-associated virus (AAV) vector-based gene therapy, for a rare type of inherited hearing loss. Regeneron plans to provide the treatmen

Confidence: 0.90 Read article →

FDA Rejection Flash Alert 2026-04-29

AbbVie's Botox Competitor Rejected by FDA on Manufacturing Concerns

AbbVie · trenibotulinumtoxinE (TrenibotE)

The FDA issued a Complete Response Letter (CRL) for AbbVie's Biologics License Application (BLA) for its prospective Botox competitor, citing manufacturing process issues. No new c

Confidence: 0.90 Read article →

EMA Approval Global Signal 2026-04-29

Sanofi's Tolebrutinib Gains EMA Backing for Multiple Sclerosis After FDA Rejection

Sanofi · Tolebrutinib

The European Medicines Agency's CHMP recommended tolebrutinib for approval in certain MS patients. This follows a complete response letter from the US FDA in December.

Confidence: 0.90 Read article →

FDA Approval Flash Alert 2026-04-29

Sanofi's Tzield Approved by FDA for Younger Children to Delay Type 1 Diabetes

Sanofi · Tzield

The FDA approved a label expansion for Tzield to delay the onset of stage 3 T1D in children as young as one year old diagnosed with stage 2 T1D.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-04-29

FDA Approves First Generic Versions of Blockbuster SGLT2 Inhibitor Farxiga

Not specified · dapagliflozin (generic)

The FDA has approved the first generic versions of dapagliflozin, known by the brand name Farxiga, a widely used SGLT2 inhibitor.

Confidence: 0.90 Read article →

Phase 3 Synthesis 2026-04-17

Eli Lilly's Jaypirca scores fourth positive Phase 3 readout in CLL, demonstrating fixed-duration power.

Eli Lilly · Jaypirca

Achieved its primary endpoint in a fourth Phase 3 trial, demonstrating efficacy as a fixed-duration treatment, an industry first for the drug in this indication.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-04-17

Ideaya and Servier's eye cancer drug meets primary endpoint, paving way for accelerated approval filing.

IDEAYA Biosciences, Servier · Unnamed eye cancer drug

The drug candidate met its primary endpoint in a pivotal Phase 2/3 trial, with plans to file for accelerated FDA approval in the second half of the year.

Confidence: 0.90 Read article →

Phase 3 Synthesis 2026-04-15

Revolution's pancreatic cancer drug nearly doubles survival in Phase 3

Revolution Medicines · Unnamed RAS inhibitor

The drug nearly doubled survival in a pivotal trial, prompting an analyst to call the results a 'game changer' for the difficult-to-treat tumor.

Confidence: 0.90 Read article →

FDA Rejection Flash Alert 2026-04-15

Replimune receives second CRL for cancer therapy, leading to layoffs

Replimune · Unnamed cancer therapy

Received a second Complete Response Letter (CRL) from the FDA for its cancer therapy, leading to multiple rounds of layoffs.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-04-15

Travere's Filspari wins expanded approval for rare kidney disease

Travere Therapeutics · Filspari (sparsentan)

Received FDA approval to reduce proteinuria in patients with FSGS, expanding its total estimated U.S. market opportunity to $3 billion.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-04-15

Lilly's Jaypirca succeeds in fourth Phase 3 CLL trial

Eli Lilly · Jaypirca (pirtobrutinib)

Achieved its fourth positive Phase 3 readout in CLL, demonstrating efficacy in a fixed-duration treatment setting, an industry first for the drug in this indication.

Confidence: 0.90 Read article →

Phase 3 Global Signal 2026-04-15

Ideaya and Servier's eye cancer drug meets primary endpoint

IDEAYA Biosciences, Servier · Unnamed eye cancer drug candidate

The drug met its primary endpoint in a pivotal Phase 2/3 trial, paving the way for a filing for accelerated FDA approval in H2 2026.

Confidence: 0.90 Read article →

FDA Rejection Synthesis 2026-04-14

Replimune receives FDA rejection for its melanoma therapy RP1.

Replimune · RP1

The FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of RP1, indicating the application cannot be approved in its present form.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-04-14

Eli Lilly's Jaypirca scores fourth positive Phase 3 readout in CLL.

Eli Lilly · Jaypirca

The BTK inhibitor achieved its primary endpoint in a Phase 3 trial, demonstrating efficacy as a fixed-duration treatment, an industry first for the drug in this indication.

Confidence: 0.90 Read article →

Phase 3 Synthesis 2026-04-14

Revolution's pancreatic cancer drug nearly doubles survival in Phase 3 trial.

Revolution · Unnamed RAS inhibitor

The drug demonstrated a near doubling of survival in a pivotal Phase 3 trial, a significant achievement in a notoriously difficult-to-treat cancer.

Confidence: 0.90 Read article →

FDA Approval Global Signal 2026-04-02

Lilly's oral GLP-1 Foundayo (orforglipron) approved for weight loss, challenging market leaders

Eli Lilly · Foundayo (orforglipron)

FDA approved the once-daily pill, which can be taken without food or water restrictions. The highest dose led to an average weight loss of 27 pounds in the ATTAIN-1 trial.

Confidence: 0.90 Read article →

Phase 3 Flash Alert 2026-04-02

AstraZeneca's Strensiq successor fails Phase 3 trial for rare metabolic disease

AstraZeneca · Strensiq successor (unnamed)

The Phase 3 trial failed to meet its primary endpoint, casting doubt on plans to expand its market reach.

Confidence: 0.90 Read article →

FDA Rejection Flash Alert 2026-04-02

Novo Nordisk lays off 400 at Indiana plant following multiple FDA rejections for client drugs

Novo Nordisk · N/A (Manufacturing Facility)

Layoffs follow FDA rejections for drugs from three different companies manufactured at the facility, citing manufacturing issues.

Confidence: 0.90 Read article →

Trial Halt Global Signal 2026-04-02

Gilead terminates mid-stage HIV trial amid ongoing FDA clinical hold

Gilead Sciences · Next-gen HIV drug (unnamed)

The company terminated a mid-stage HIV trial, with an FDA clinical hold on two of its next-gen HIV drugs remaining in place since last June.

Confidence: 0.90 Read article →

Phase 3 Global Signal 2026-04-02

Precision immunotherapy shows promise in sepsis, improving organ dysfunction in Phase 3 trial

N/A (ImmunoSep trial) · Precision immunotherapy (unnamed)

Confidence: 0.90 Read article →

Daily intelligence.Four regulators.One pipeline.

Daily intelligence.
Four regulators.
One pipeline.