FiercePharma7h
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
FDA Public Meeting Reveals Federal Support For Psychedelics In PTSD Care
This gathering came shortly after the FDA’s decision to decline Lykos Therapeutics' application for midomafetamine ...
Hosted on MSN1d
IMNN: Meeting with FDA in Preparation for Phase 3 Ovarian Cancer Trial
As part of the process, the company will be conducting an ‘End-of-Phase 2’ meeting with the FDA later this month to get input from the agency on their proposed trial design. The study is likely to ...
Altimmune Announces Successful Completion of End-of-Phase 2 Meeting with FDA for Pemvidutide in the Treatment of Obesity
Company and Agency aligned on key efficacy and safety measures to be studied in Phase 3 programPivotal Phase 3 trials designed to leverage the ...
Targeted Oncology6d
FDA Clears Phase 2 Trial of Leronlimab for Microsatellite-Stable CRC
The FDA recently approved a phase 2 clinical trial to investigate the efficacy of leronlimab in patients with relapsed or ...
Liam Payne's Alleged Drug Dealer Confirms Meeting At Hotel; Took Pics Together
Braian Paiz, the alleged drug dealer of former One Direction member Liam Payne, has spoken up about their encounters. In an exclusive interview, Paiz claims they met at a hotel, where the two even ...
Telangana to set up four new drug testing labs
Minister for Health plans to establish four new drug testing labs in Telangana to improve drug quality monitoring.
FDA proposes ending use of decongestant found in many cold, allergy medicines
An extensive review determined that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion.
Kazia Therapeutics Advances Paxalisib with FDA Meeting
Kazia Therapeutics (KZIA) has released an update. Kazia Therapeutics has announced a significant development in its quest to advance paxalisib, ...
MassDevice12h
Johnson & Johnson wins FDA IDE for Ottava surgical robot
Johnson & Johnson MedTech announced today that the FDA granted its Ottava surgical robot investigational device exemption ...
Medscape4d
FDA Approved Obe-cel, a Novel CD19 CAR T Product for ALL
Obe-cel was designed to increase T-cell persistence and reduce T-cell exhaustion and was shown to improve response rates and survival, particularly in patients with low leukemia burden.