Browsing Tag
FDA
341 posts
FDA committee endorses Zevra Therapeutics’ arimoclomol as a treatment for Niemann-Pick Disease Type C
In a notable advancement for rare disease treatment, Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) has received a significant endorsement…
Vertex Pharmaceuticals’ suzetrigine approved for FDA review: A breakthrough in pain management
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) has announced a pivotal advancement in the treatment of acute pain. The U.S.…
Setback for diabetes innovation: FDA puts brakes on Novo Nordisk’s once-weekly insulin icodec
Novo Nordisk announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)…
Genentech announces reintroduction of Susvimo for Wet AMD treatment in US
Genentech, a key member of the Roche Group, has officially announced the reintroduction of Susvimo (ranibizumab injection) 100…
Swedish Match aims to renew and expand modified risk tobacco product status in US
Swedish Match USA, Inc., part of the Philip Morris International Inc. (NYSE: PM) family, made a significant presentation…
Lilly announces significant results in SURMOUNT-OSA trials of tirzepatide in OSA
Eli Lilly and Company (NYSE: LLY) has released positive topline results from the phase 3 SURMOUNT-OSA clinical trials,…
Argenica Therapeutics’ ARG-007 gets FDA orphan drug status in hypoxic ischaemic encephalopathy
Argenica Therapeutics Limited (ASX: AGN), a leading biotechnology company specializing in developing therapeutics for brain injuries and neurological…
Lupin secures FDA nod for generic Bromday Ophthalmic Solution
Global pharmaceutical titan, Lupin Limited, has officially declared its success in securing the esteemed approval from the United…
Narcan nasal spray becomes the first OTC naloxone product approved by the FDA for opioid overdose treatment
Emergent BioSolutions’ Narcan nasal spray is now FDA-approved for over-the-counter use. Find out how this could change the fight against opioid overdoses.
Ayala Pharmaceuticals AL102 gets FDA fast track status in desmoid tumors
Ayala Pharmaceuticals has been granted fast track designation for its oral gamma-secretase inhibitor AL102 by the US Food…