Browsing Tag
US Food and Drug Administration
333 posts
BriaCell Therapeutics’ Bria-IMT gets FDA fast track status in breast cancer
BriaCell Therapeutics has secured the fast track status from the US Food and Drug Administration (FDA) for its…
Axsome Therapeutics to acquire Sunosi from Jazz Pharmaceuticals
Axsome Therapeutics has agreed to acquire Sunosi (solriamfetol), an approved dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), from…
Pfizer RSVpreF vaccine candidate gets another FDA breakthrough therapy status
Pfizer said that PF-06928316 (RSVpreF), its respiratory syncytial virus (RSV) vaccine candidate, has been granted breakthrough therapy designation…
FDA rejects Lilly’s sintilimab as first line treatment of NSCLC
The US Food and Drug Administration (FDA) has rejected the biologics license application (BLA) of Eli Lilly and…
FDA refuses to approve AstraZeneca’s sBLA for Fasenra in CRSwNP
The US Food and Drug Administration (FDA) has refused to approve the supplemental biologics license application (sBLA) of…
Lupin secures FDA approval to launch generic vigabatrin oral solution in the US market
Lupin secures US FDA approval for generic vigabatrin oral solution, a $275M epilepsy drug, boosting its US generics and neurology portfolio.
Harpoon Therapeutics gets FDA fast track status for HPN217 in RRMM
Harpoon Therapeutics has bagged fast track designation for HPN217 from the US Food and Drug Administration (FDA) for…
Pfizer gets FDA breakthrough status for RSVpreF RSV vaccine candidate
Pfizer has secured breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate — PF-06928316 (RSVpreF) from…
Lantheus gets FDA approval for drug manufacturing facility in Billerica
Lantheus Holdings has secured approval from the US Food and Drug Administration (FDA) for the supplemental drug application…
Agios Pharmaceuticals gets PYRUKYND FDA approval for hemolytic anemia
Agios Pharmaceuticals has secured approval for PYRUKYND (mitapivat) from the US Food and Drug Administration (FDA) for the…