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Guardant Health's Guardant360 CDx wins FDA approval as companion diagnostic for AstraZeneca's Etcamah (camizestrant) in ESR1-mutated hormone receptor-positive, HER2-negative metastatic breast cancer
Small molecule, cancer, companion diagnostic, breast cancer, ESR1 mutation, liquid biopsy - Read more

AstraZeneca's Etcamah (camizestrant) wins FDA approval for ESR1-mutated hormone receptor-positive, HER2-negative advanced breast cancer following Ph3 trial
Small molecule, cancer, SERD, breast cancer, ESR1 mutation, CDK4/6 inhibitor combination - Read more

Shionogi's (cefiderocol) wins Australia TGA approval for carbapenem-resistant Gram-negative bacterial infections based on Ph2/Ph3 trials
Small molecule, infectious disease, cephalosporin, antibiotic resistance, carbapenem-resistant gram-negative bacteria, urinary tract infection - Read more

ProBioGen, Transgene expand strategic partnership with additional AGE1.CR.pIX cell line license agreement
Licensing deal, manufacturing, vaccine, oncology, cell therapy - Read more

Aptar Pharma, Aceso Therapeutics collaborate to advance inhaled antisense oligonucleotide therapy ACT-101 for cystic fibrosis
Research collaboration, rare disease, antisense oligonucleotide, inhaled drug delivery, formulation development - Read more

Flow Technology partners with BW Forsyth Partners to expand biopharmaceutical manufacturing capabilities in the US and Europe
Manufacturing agreement, biopharmaceutical manufacturing, equity investment, downstream purification, life sciences - Read more

MOLCURE, Axcelead Drug Discovery Partners collaborate to discover peptide drug candidates using AI-driven platform
Research collaboration, AI/ML, drug discovery, peptide, R&D - Read more

Cell and Gene Live is a one-day, investor & CEO summit dedicated exclusively to Cell and Gene therapy - the science, the manufacturing, and the investment driving advanced medicines forward. All happening on November 15, 2026.

(Hosted by Onyx at The Shard in London as part of London Life Sciences Week)

Speakers confirmed include:

• Steve Bates, OBE (Chair of the UK's Department of Life Sciences)
• Dr. Erik Wiklund (CEO of Circio)
• Edwin Stone (CEO of Cellular Origins)
+ many more!

Get your tickets here - for TLDR Biotech readers, use code ANIS20 at check-out for 20% off.

Bristol Myers Squibb's (arlocabtagene autoleucel) Ph3 trial meets primary endpoint in GPRC5D-targeted relapsed or refractory multiple myeloma
Cell therapy, cancer, CAR-T, multiple myeloma, GPRC5D target, bispecific antibody - Read more

Pharvaris' (deucrictibant) hits Ph3 primary endpoint, strengthening bradykinin B2 receptor case for hereditary angioedema with FDA verdict pending
Small molecule, autoimmune, bradykinin B2 receptor antagonist, hereditary angioedema, prophylactic therapy - Read more

Spyre Therapeutics' SPY003 (anti-interleukin-23 antibody) hits Ph2 endpoints in ulcerative colitis, completing trio of wins
Antibody, autoimmune, monoclonal antibody, ulcerative colitis, IL-23, combination therapy - Read more

Novo Nordisk's Wegovy (semaglutide) frees 40% of children from obesity in Ph3 trial
Small molecule, metabolic, GLP-1 receptor agonist, obesity, pediatric population, semaglutide - Read more

Roivant Sciences' (mosliciguat) meets primary endpoint in Ph2, reducing pulmonary vascular resistance in pulmonary hypertension associated with interstitial lung disease
Small molecule, cardiovascular, pulmonary hypertension, soluble guanylate cyclase stimulator, interstitial lung disease - Read more

Structure Therapeutics reports Ph3-ready aleniglipron (GLP-1) and Ph1/2a ACCG-2671 (dual amylin and calcitonin receptor) obesity data
Small molecule, metabolic, obesity, GLP-1 receptor agonist, amylin receptor agonist, oral drug - Read more

Inhibrx Biosciences' INBRX-106 beats Merck & Co.'s Keytruda (pembrolizumab) alone in Ph2 head and neck squamous cell carcinoma trial
Antibody, cancer, OX40 agonist, head and neck squamous cell carcinoma, combination therapy, Keytruda - Read more

Stoke Therapeutics, Biogen share four-year Ph1/Ph2 data for (zorevunersen) targeting SCN1A in Dravet syndrome
Antisense oligonucleotide, neurological, Dravet syndrome, SCN1A, seizure reduction - Read more

Clover Biopharmaceuticals' (SCB-1022/SCB-1033) combo respiratory vaccines show strong Ph2 results against respiratory syncytial virus, human metapneumovirus, and human parainfluenza virus
Vaccine, infectious disease, protein-based vaccine, RSV, combination vaccine, older adults - Read more

Epicyt Pharma reports positive Ph1/2a results for BAFA targeting impaired calcium uptake after gastric bypass surgery
Small molecule, metabolic, oral drug, bariatric surgery, calcium homeostasis, secondary hyperparathyroidism - Read more

Upstream Bio's (verekitug) meets primary endpoint in Ph2 trial, reducing severe asthma exacerbations by 56%
Antibody, autoimmune, monoclonal antibody, severe asthma, TSLP receptor antagonist - Read more

ADARx Pharmaceuticals plans IPO to fund clinical-stage siRNA therapies across multiple diseases
siRNA, clinical-stage, rare disease, cardiovascular, neurological, autoimmune - Read more

BrainChild Bio raises $116M venture financing to develop CAR-T therapies for childhood brain cancers
Cell therapy, CAR-T, pediatric oncology, rare disease, clinical-stage - Read more

Moonwalk Biosciences raises $70M Series B to advance RNAi obesity candidate to clinic
Obesity, RNAi, adipose tissue, AI/ML platform, preclinical - Read more

Polyrizon raises $4M via registered direct offering and private placement, intranasal hydrogel development
Intranasal drug delivery, hydrogel platform, preclinical, development-stage - Read more

ANRis Inc. raises JPY 220M ($1.41M) to advance siRNA therapeutics targeting KRAS-mutant cancer
Oncology, siRNA, KRAS, preclinical, platform technology - Read more

Vaxdyn raises €11M ($12.77M) Series A, led by Biovance Capital, advancing AMR vaccines to clinic
Infectious disease, vaccine, antimicrobial resistance, clinical-stage - Read more

Sandoz invests ~$300M in Ljubljana biosimilar drug substance facility, expanding manufacturing capacity by 2029
Biosimilar, major transaction, operational, strategic - Read more

Do you offer a biotech/pharma-focused product or service?

Or looking to get investor/analyst interest on your budding start-up?

Considering sponsoring TLDR Biotech to get in-front of an engaged audience of biotech & pharma-focused professionals.

Just reply to this email* or message me on LinkedIn to learn more.

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Novartis, Ionis Pharmaceuticals' pelacarsen fails Ph3 trial for major cardiovascular events despite lowering lipoprotein(a)
RNA therapy, cardiovascular, antisense oligonucleotide, lipoprotein(a), phase 3 trial - Read more

Novo Nordisk scraps Ph3 Hermes and Athena trials of (ziltivekimab) targeting IL-6 for heart failure
Antibody, cardiovascular, monoclonal antibody, heart failure, IL-6 inhibitor, chronic kidney disease - Read more

Novartis' (del-desiran) fails Ph3 HARBOR trial in myotonic dystrophy type 1, missing primary hand function endpoint
Antibody-oligonucleotide conjugate, neuromuscular disease, myotonic dystrophy type 1, siRNA, transferrin receptor 1, DMPK - Read more

American Regent recalls three epinephrine batches due to particulate contamination and leaking vial concerns
Small molecule, allergy and anaphylaxis, product recall, operational - Read more

Boston Scientific recalls spinal cord implant after 1,081 serious injuries linked to potential lead breakage
Spinal cord implant, chronic pain, operational, safety recall - Read more

FDA finalises withdrawal of Bristol Myers Squibb's Krazati colorectal cancer indication after confirmatory trial failure
Small molecule, colorectal cancer, competitive, regulatory - Read more

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