FDA Issues Draft Guidance, Updates Staff Manual to Speed ANDA Reviews
In a move aimed at speeding reviews of generics this year, the FDA released a new draft guidance on ANDAs for public comment along with an updated Manual of Policies…
In a move aimed at speeding reviews of generics this year, the FDA released a new draft guidance on ANDAs for public comment along with an updated Manual of Policies…
The therapy is the first type approved by the FDA that targets a disease caused by mutations in a specific gene. Source: BioSpace
The company said the Breakthrough Therapy Designation is based on positive results from the Phase III MONALEESA-7 trial. Source: BioSpace
Indivior today announced that Indivior UK Limited has entered into a strategic collaboration with Addex, in the field of GABAB PAMs. Source: BioSpace
Syntimmune has appointed Jean-Paul Kress as president and CEO. Source: BioSpace
The new 7600 square feet custom-built, state-of-the-art facility hosts Denovo's biomarker discovery platform, US clinical team and serves as Denovo's US headquarters. Source: BioSpace
BlueRock Therapeutics, which has locations in Toronto, NYC and Cambridge, Mass., rocketed to existence in December 2016 with $225M in venture funding to focus on regenerative medicine, using iPSC therapies.…
The round was co-led by 5AM Ventures, Kleiner Perkins, Novartis Venture Fund, and Sanofi Ventures. Source: BioSpace
The annual Hotbed Maps have guided professionals in their career paths all across the country and abroad. Source: BioSpace
The funds will be used to expand its growing pipeline and progress several early stage molecules towards the clinic. Source: BioSpace