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Breakthrough Therapy Designation

Showing 15 posts of 15 posts found.

J&J’s nipocalimab gains breakthrough therapy designation from FDA for HDFN treatment

February 12, 2024
Medical Communications Breakthrough Therapy Designation, FDA, HDFN, J&J, Reproductive health

Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) …

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Grünenthal receives FDA Breakthrough Therapy Designation for knee osteoarthritis drug

May 23, 2023
Medical Communications Breakthrough Therapy Designation, FDA, Grunenthal, Musculo-skeletal disorder, osteoarthritis

German pharmaceutical company Grünenthal has announced that the US Food and Drug Administration (FDA) has awarded it Breakthrough Therapy Designation …

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Magic mushroom ingredient psilocybin gains breakthrough therapy designation

October 26, 2018
Medical Communications Breakthrough Therapy Designation, Compass, FDA, Magic mushrooms, psylicobin

The US Food and Drug Administration (FDA) has given psilocybin – the psychoactive ingredient in ‘magic mushrooms’ – breakthrough therapy …

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Gamida Cell receives Breakthrough Therapy Designation from FDA

October 12, 2016
Research and Development Breakthrough Therapy Designation, FDA, Gamida Cell, leukaemia, lymphoma

Gamida Cell have been granted a Breakthrough Therapy Designation for their NiCord drug. NiCord has already passed through Phase I …

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novartis_building

Breakthrough therapy designation for Novartis in advanced breast cancer treatment

August 3, 2016
Research and Development, Sales and Marketing Breakthrough Therapy Designation, FDA, LEE011, Novartis, ribociclib

Novartis has announced that the US Food and Drug Administration (FDA) has granted a breakthrough therapy designation to LEE011 (ribociclib) …

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Bristol-Myers Squibb’s Opdivo gets US FDA breakthrough therapy designation for advanced bladder cancer

June 28, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Breakthrough Therapy Designation, Bristol-Myers Squibb, FDA, bladder cancer, opdivo, regulation

Bristol-Myers Squibb (NYSE:BMY) said the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to its immunotherapy Opdivo for the …

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shire_image_4

Shire gets FDA breakthrough therapy designation for two rare disease drugs

June 13, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Breakthrough Therapy Designation, Shire, US FDA, rare disease, rare disease drugs

Ireland headquartered Shire (LSE: SHP) on Monday said the US Food and Drug Administration (FDA) has granted breakthrough therapy designation …

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novartis_outside_1

Novartis’ Ilaris gets US FDA breakthrough therapy designation to treat fever syndromes

April 27, 2016
Business Services, Research and Development Breakthrough Therapy Designation, Novartis, US FDA, periodic fever syndromes

Novartis (VTX: NOVN) on Wednesday said its drug to treat three rare types of periodic fever syndromes has been granted …

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keytruda1

MSD receives fourth Breakthrough Therapy Designation for Keytruda

April 19, 2016
Manufacturing and Production, Research and Development Breakthrough Therapy Designation, FDA, Hodgkin lymphoma, MSD, Merck, breakthrough designation, breakthrough therapy, keytruda

MSD (NYSE: MRK) has announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab) …

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Lynparza

AZ’s Lynparza gets prostate cancer breakthrough status

January 28, 2016
Sales and Marketing AstraZeneca, Breakthrough Therapy Designation, FDA, lynparza, olaparib, prostate cancer

AstraZeneca’s Lynparza has been granted breakthrough therapy designation by the FDA as a monotherapy for the treatment of a specific …

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FDA logo

AbbVie/Roche’s venetoclax bags FDA Breakthrough Therapy Designation

January 21, 2016
Sales and Marketing AbbVie, Breakthrough Therapy Designation, FDA, Roche, venetoclax

AbbVie and Roche’s cancer drug venetoclax has been granted Breakthrough Therapy Designation by the FDA in combination with rituximab for …

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Eisai logo

FDA grants Eisai’s Lenvima priority review for kidney cancer

January 19, 2016
Manufacturing and Production Breakthrough Therapy Designation, Eisai, FDA, Kidney cancer, Lenvima, lenvatinib, priority review, renal cell carcinoma

The FDA has accepted Eisai’s supplemental New Drug Application (sNDA) for its anti-cancer agent Lenvima for use in the treatment …

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FDA grants Opdivo breakthrough status for kidney cancer

September 18, 2015
Research and Development, Sales and Marketing BMS, Breakthrough Therapy Designation, Bristol-Myers Squibb, FDA, Kidney cancer, immuno-oncology, immunotherapy, nivolumab, opdivo, renal cell carcinoma

The FDA has given Bristol-Myers Squibb’s immuno-oncology drug Opdivo Breakthrough Therapy Designation as a kidney cancer treatment. The FDA’s decision …

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Abbvie and Roche report success in Phase II leukaemia trial

August 13, 2015
Research and Development AbbVie, Breakthrough Therapy Designation, CLL, EMA, FDA, Roche, chronic lymphocytic leukaemia, leukaemia, venetoclax

AbbVie plans to submit regulatory applications for its leukaemia drug venetoclax to the FDA and the EMA before the end …

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Heart failure treatment given Breakthrough Status

June 27, 2013
Sales and Marketing Breakthrough Therapy Designation, Novartis, RLX03O, serelaxin

Novartis’ new treatment for heart failure has been granted Breakthrough Therapy designation status by the FDA. RLX030 (serelaxin) is for …

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