FDA grants accelerated approval for Alzheimer’s drug

7 June 2021 - Today, the U.S. FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 ...

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FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer

21 May 2021 - Today, the FDA granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen), a bispecific antibody directed against epidermal ...

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FDA grants accelerated approval to pembrolizumab for HER2 positive gastric cancer

5 May 2021 - Today the FDA granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, ...

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Curtailing Medicaid coverage of accelerated approval therapies threatens patients' access

3 May 2021 - To improve their COVID-battered fiscal situations, some states are looking to cut Medicaid, which makes up ...

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Bristol Myers Squibb statement on FDA Advisory Committee meeting on Opdivo post sorafenib hepatocellular carcinoma U.S. indication

29 April 2021 - As part of its industry-wide review of accelerated approvals in oncology without confirmatory benefit, the U.S ...

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FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for previously untreated metastatic bladder cancer

28 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 10 to 1 in favour of ...

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FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for PD-L1 positive, metastatic triple negative breast cancer

27 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 7 to 2 in favour of ...

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“Dangling” accelerated approvals in oncology

21 April 2021 - The FDA recently reevaluated accelerated approvals for 35 oncology indications for anti–programmed death ligand 1 antibodies, revealing ...

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FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis

15 January 2021 - Today, the FDA granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) in combination ...

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FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow

25 November 2020 - On 24 November 2020, the FDA granted accelerated approval to naxitamab (Danyelza, Y-mAbs Therapeutics) in combination with ...

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Pathological complete response in neo-adjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval

29 July 2020 - This guidance is intended to assist sponsors in designing trials to support marketing approval of medicines and ...

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U.S. FDA approves Opdivo (nivolumab) + Yervoy (ipilimumab) for patients with hepatocellular carcinoma previously treated with sorafenib

11 March 2020 - Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting. ...

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FDA approves voxelotor for sickle cell disease

25 November 2019 - The Food and Drug Administration has granted accelerated approval to voxelotor (Oxbryta, Global Blood Therapeutics) for ...

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FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumour shrinkage

14 November 2019 - Today, the U.S. FDA granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients ...

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Fast-track drug approval, designed for emergencies, is now routine

5 July 2019 - Three-quarters of new drugs get an expedited regulatory review, thrusting families and doctors into a new world ...

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