Breakthrough Therapy Designation
FDA grants accelerated approval for advanced non-small cell lung cancer treatment
July 4, 2025Medical Communications, Research and Development Breakthrough Therapy Designation, Oncology, US Food and Drug Administration, Zegfrovy, clinical trial, non-small cell lung cancer, priority review
The US Food and Drug Administration (FDA) has granted accelerated approval to Dizal Therapeutic’s Zegfrovy (sunvozertinib) for the treatment of …
J&J’s nipocalimab gains breakthrough therapy designation from FDA for HDFN treatment
February 12, 2024Medical 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) …
Grünenthal receives FDA Breakthrough Therapy Designation for knee osteoarthritis drug
May 23, 2023Medical 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 …
Magic mushroom ingredient psilocybin gains breakthrough therapy designation
October 26, 2018Medical 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 …
Gamida Cell receives Breakthrough Therapy Designation from FDA
October 12, 2016Research 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 …
Breakthrough therapy designation for Novartis in advanced breast cancer treatment
August 3, 2016Research 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) …
Bristol-Myers Squibb’s Opdivo gets US FDA breakthrough therapy designation for advanced bladder cancer
June 28, 2016Manufacturing 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 …
Shire gets FDA breakthrough therapy designation for two rare disease drugs
June 13, 2016Manufacturing 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 …
Novartis’ Ilaris gets US FDA breakthrough therapy designation to treat fever syndromes
April 27, 2016Business 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 …
MSD receives fourth Breakthrough Therapy Designation for Keytruda
April 19, 2016Manufacturing 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) …
AZ’s Lynparza gets prostate cancer breakthrough status
January 28, 2016Sales 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 …
AbbVie/Roche’s venetoclax bags FDA Breakthrough Therapy Designation
January 21, 2016Sales 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 …
FDA grants Eisai’s Lenvima priority review for kidney cancer
January 19, 2016Manufacturing 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 …
FDA grants Opdivo breakthrough status for kidney cancer
September 18, 2015Research 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 …
Abbvie and Roche report success in Phase II leukaemia trial
August 13, 2015Research 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 …
Latest content
NIHR chief scientific adviser visits Huddersfield health innovation campus
One in three UK women with migraine say symptoms taken less seriously
Report highlights scope to expand day surgery
Sygnature formalises drug discovery collaboration with X-Chem
Codis appoints Steven Facer as chief commercial officer
