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FDA expands Bayer's Hyrnuo (zipalertinib) approval to first-line HER2-mutant non-small cell lung cancer via Ph1/2 data
Small molecule, cancer, tyrosine kinase inhibitor, non-small cell lung cancer, HER2 mutation, precision medicine - Read more

NICE backs Johnson & Johnson's Imbruvica (ibrutinib) regimen for previously untreated mantle cell lymphoma following Ph3 success
Small molecule, cancer, BTK inhibitor, mantle cell lymphoma, non-Hodgkin lymphoma, combination therapy - Read more

Samsung Biologics secures $262M biologics manufacturing deal with unnamed European pharmaceutical company
Manufacturing agreement, biologics, CDMO, peptide, small molecule - Read more

EMD Serono acquires PostEra's two AI-discovered fertility programs targeting FSHR and LHCGR agonists
Acquisition, small molecule, AI/ML, women's health, fertility, drug discovery - 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.

AbbVie's Qulipta (atogepant) hits Ph3 primary endpoint for calcitonin gene-related peptide receptor in menstrual migraine
Small molecule, neurological, CGRP receptor antagonist, migraine, menstrual migraine, atogepant - Read more

Rezera's (ruvonoflast) Ph2 RESOLVE-1 trial meets primary endpoint in peripheral artery disease, targeting NLRP3
Small molecule, cardiovascular, NLRP3 inhibitor, peripheral artery disease, neurological, inflammation - Read more

Disc Medicine shares positive Ph2 data for (DISC-3405) targeting hepcidin/iron in polycythemia vera patients
Antibody, cancer, monoclonal antibody, polycythemia vera, hepcidin, myeloproliferative neoplasms - Read more

Belenos Biosciences reports positive Ph1b interim results for BEL512 (BEL512) targeting TSLP/interleukin-13 in mild-moderate asthma
Antibody, autoimmune, bispecific antibody, asthma, TSLP/IL-13 target - Read more

Frazier Life Sciences nets $1.1B for public fund targeting small, mid-cap biotechs
Biotech investing, venture capital, small molecule, public markets - Read more

Connecta Therapeutics raises €3.1M ($3.6M) in funding to expand neuroplasticity modulator development efforts
Neurological, small molecule, CNS disorders, rare disease, platform-enabled - Read more

TwoStep Therapeutics raises $62.5M Series A, advancing multi-specific targeted therapies for solid tumors
Oncology, peptide-drug conjugate, solid tumors, radioligand therapy, multi-specific, clinical-stage - Read more

CordenPharma expands aseptic fill-finish capacity to 500 million sterile injectable units annually with €80M ($93.1M) investment
Sterile injectable, oncology, operational, major transaction - Read more

Lonza to build large-scale commercial spray-drying facility in Bend, Oregon, expanding US CDMO capabilities
Small molecule, bioavailability enhancement, CDMO, operational, manufacturing - Read more

ABPI reports £2B ($2.71B) pharma investment surge in UK, signaling reversal of disinvestment trend
Pharmaceutical investment, strategic, financial, regulatory, operational - Read more

nPhase launches AI clinical data management platform nPhase.ai to accelerate trial submission timelines
AI platform, clinical trials, operational, cost reduction - 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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NICE rejects Gilead Sciences' twice-yearly lenacapavir PrEP drug from NHS coverage citing cost, clinical uncertainties
Long-acting injectable, infectious disease, regulatory, financial - Read more

FDA places partial clinical hold on Biohaven's opakalim epilepsy drug, pausing trial recruitment
Small molecule, epilepsy, regulatory, financial - Read more

Artisan Partners calls for Novartis board overhaul following costly pipeline failures and acquisition setbacks
Antibody-oligonucleotide conjugate, cardiovascular, corporate governance, major transaction - Read more

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