Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

FDA approves Sarclisa + VRd for MM not eligible for transplant

FDA approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.

September 27, 2024

Vol.50 No.36

Drugs & Targets

FDA approves Tagrisso for stage 3 EGFR-mutated NSCLC

FDA approved Tagrisso (osimertinib) in the U.S. for treatment of adult patients with unresectable, stage 3 epidermal growth factor receptor-mutated non-small cell lung cancer whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy.

September 27, 2024

Vol.50 No.36

Regulatory News

Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover design
The agency accepts the invitation

A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.

NIH study links neighborhood environment to prostate cancer risk in men with West African genetic ancestry

West African genetic ancestry was associated with increased prostate cancer among men living in disadvantaged neighborhoods but not among men living in more affluent neighborhoods, according to a new study led by NIH researchers. The findings suggest that neighborhood environment may play a role in determining how genetic ancestry influences prostate cancer risk.

September 20, 2024

Vol.50 No.35

Drugs & Targets

FDA approves Keytruda + pemetrexed + chemo in first-line mesothelioma indication

FDA has approved Keytruda in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma.

September 20, 2024

Vol.50 No.35

Drugs & Targets

FDA approves Rybrevant + pemetrexed + chemo in NSCLC with EGFR exon 19 deletions or L858R mutations

FDA approved Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

September 20, 2024

Vol.50 No.35

Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

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FDA approves Sarclisa + VRd for MM not eligible for transplant

FDA approves Tagrisso for stage 3 EGFR-mutated NSCLC

Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover design
The agency accepts the invitation

NIH study links neighborhood environment to prostate cancer risk in men with West African genetic ancestry

FDA approves Keytruda + pemetrexed + chemo in first-line mesothelioma indication

FDA approves Rybrevant + pemetrexed + chemo in NSCLC with EGFR exon 19 deletions or L858R mutations

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Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

YOU MAY BE INTERESTED IN

FDA approves Sarclisa + VRd for MM not eligible for transplant

FDA approves Tagrisso for stage 3 EGFR-mutated NSCLC

Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover designThe agency accepts the invitation

NIH study links neighborhood environment to prostate cancer risk in men with West African genetic ancestry

FDA approves Keytruda + pemetrexed + chemo in first-line mesothelioma indication

FDA approves Rybrevant + pemetrexed + chemo in NSCLC with EGFR exon 19 deletions or L858R mutations

Can you spare 10 minutes to complete a survey?

Login

Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover design
The agency accepts the invitation