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Representative image: An oncologist discusses subcutaneous lung cancer treatment with a patient. The recent FDA approval of RYBREVANT FASPRO for EGFR-mutated NSCLC highlights a shift toward faster, chemotherapy-free options.
Pharma & Biotech

FDA clears subcutaneous RYBREVANT FASPRO for first-line EGFR+ NSCLC: What this changes for patients and providers

The U.S. Food and Drug Administration has approved Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), the first subcutaneous version of its bispecific EGFR-MET antibody therapy, for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval spans all current RYBREVANT indications and is based on the Phase 3 PALOMA-3 study, which demonstrated comparable pharmacokinetics

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Pharma & Biotech

Innovent’s mazdutide earns Nature spotlight: Are dual GCG/GLP-1 agonists set to reshape diabetes and obesity care?

Innovent Biologics, Inc. has achieved a landmark moment in China’s clinical research trajectory with the back-to-back publication of two Phase 3 clinical trials of mazdutide, a dual GCG/GLP-1 receptor agonist, in Nature as Accelerated Article Previews. These studies, known as DREAMS-1 and DREAMS-2, evaluated the drug as monotherapy and as an add-on therapy in Chinese

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Representative image of transcription factor and protein–protein interaction drug discovery, reflecting PRISM BioLab and Talus Bio’s AI-powered strategy to target undruggable intracellular pathways.
Pharma & Biotech

Can PRISM BioLab and Talus Bio finally drug the undruggable with AI and PPI chemistry?

PRISM BioLab and Talus Bio aim to drug the undruggable with AI–PPI chemistry. Find out how this platform could transform transcription factor drug discovery.

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Representative image: Indivior’s SUBLOCADE 300 mg dose is gaining attention for its potential to improve outcomes in high-frequency fentanyl users, signaling a shift in opioid use disorder treatment strategies.
Pharma & Biotech

Indivior’s SUBLOCADE shows stronger outcomes in high-frequency fentanyl users: What this changes for opioid use disorder treatment in 2026

Indivior's new data shows SUBLOCADE 300 mg may improve outcomes in fentanyl users with OUD. Find out what this means for future treatment.

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Pharma & Biotech

GSK’s Exdensur wins FDA nod for severe asthma: Can twice-yearly dosing reset the biologics playbook?

GSK’s Exdensur has been approved by the FDA as the first biannual biologic for severe asthma. Find out what this means for patients, payers, and rivals.

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Pharma & Biotech

Can Harbour BioMed’s deal with Bristol Myers Squibb redefine the future of multispecific antibodies?

Harbour BioMed has signed a global strategic collaboration and license agreement with Bristol Myers Squibb to discover and develop next-generation multispecific antibodies. The deal could be worth over $1.1 billion across upfront payments, milestones, and royalties. It also signals growing interest in platforms capable of generating novel immunotherapies for complex diseases. The announcement is not

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Pharma & Biotech

Enhertu plus pertuzumab receives FDA approval for 1st-line HER2-positive metastatic breast cancer: Is the new standard of care here?

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (trastuzumab deruxtecan), in combination with pertuzumab, has received U.S. Food and Drug Administration approval as a first-line treatment for patients with unresectable or metastatic HER2-positive breast cancer, based on results from the DESTINY-Breast09 Phase III trial. The approval marks the first new frontline treatment in over a decade

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AstraZeneca’s Saphnelo pen approved in EU as biologic lupus treatment advances
Pharma & Biotech

AstraZeneca gains EU approval for Saphnelo self-injection pen in lupus treatment

AstraZeneca has received European Commission approval for a new subcutaneous formulation of Saphnelo (anifrolumab), allowing adult patients with systemic lupus erythematosus (SLE) to self-administer the drug via a once-weekly pre-filled pen. The regulatory decision follows a positive opinion from the Committee for Medicinal Products for Human Use and is supported by data from the Phase

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Pharma & Biotech

What OrsoBio’s Phase 1b/2a TLC-6740 results reveal about the limits of GLP-1 monotherapy

OrsoBio’s TLC-6740 combo data hints at a new way to break GLP-1 plateaus. Read what this could change in obesity drug development.

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Cosette Pharmaceuticals and the quiet commercial power of Competitive Generic Therapy exclusivity
Pharma & Biotech

What Cosette Pharmaceuticals’ first generic ciprofloxacin hydrocortisone launch reveals about FDA CGT incentives

Cosette Pharmaceuticals launches the first generic ciprofloxacin hydrocortisone otic suspension. Find out what this FDA CGT approval really changes.

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