FDA

Lilly wins FDA approval for second interchangeable insulin biosimilar
Endpoints
Thu, 11/17/22 - 11:27 pm
Eli Lilly
FDA
insulin
diabetes
biosimilars
With the walls closing in for Clovis, FDA demands ovarian cancer restriction for Rubraca
Fierce Biotech
Thu, 11/17/22 - 10:52 am
Clovis Oncology
Rubraca
ovarian cancer
FDA
In surprise turn, FDA adcomm votes in favor of Ardelyx CKD drug despite agency questions
Endpoints
Wed, 11/16/22 - 11:30 pm
Ardelyx
FDA
chronic kidney disease
tenapanor
FDA relaxes EUA advertising limitation for some COVID drugs
RAPS.org
Wed, 11/16/22 - 11:20 pm
FDA
COVID-19
pharma advertising
regulatory
FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use
FDA
Wed, 11/16/22 - 10:44 am
FDA
Naloxone
opioids
opioid crisis
opioid overdose
FDA bestows accelerated approval on ImmunoGen's ovarian cancer drug, with confirmatory answer coming soon
Endpoints
Tue, 11/15/22 - 10:41 am
Immunogen
FDA
ovarian cancer
mirvetuximab soravtansine
BrainStorm Vows to Push for Adcomm Meeting on NurOwn in ALS
BioSpace
Mon, 11/14/22 - 10:53 am
BrainStorm Cell Therapeutics
NurOwn
ALS
FDA
FDA accepts Amneal’s NDA for IPX203 to treat Parkinson’s disease
Pharmaceutical Business Review
Mon, 11/14/22 - 10:31 am
Amneal
FDA
IPX203
Parkinson's Disease
GSK Restricts the Use of PARP Inhibitor in Ovarian Cancer at the FDA's Request
BioSpace
Sun, 11/13/22 - 07:07 pm
GSK
ovarian cancer
Zejula
PARP inhibitors
FDA
Seagen's highest selling drug snags a label expansion for pediatric cancer patients
Endpoints
Sun, 11/13/22 - 07:01 pm
Seagen
Takeda
Adcetris
Hodgkin's lymphoma
FDA
pediatric
AZ claims another Imjudo approval, in big first-line NSCLC market
Pharmaphorum
Fri, 11/11/22 - 10:53 am
AstraZeneca
FDA
Imjudo
non-small cell lung cancer
FDA grants IND clearance for Asieris’ ulcerative colitis drug trial
Clinical Trials Arena
Fri, 11/11/22 - 10:40 am
FDA
Asieris Pharmaceutical
APL-1401
ulcerative colitis
clinical trials
Not once, but twice: BrainStorm shares tumble as FDA again knocks back ALS drug
Fierce Biotech
Thu, 11/10/22 - 10:32 am
BrainStorm Cell Therapeutics
ALS
FDA
NurOwn
FDA signs off on Sobi's Kineret for COVID patients with pneumonia who are on oxygen
Fierce Pharma
Wed, 11/9/22 - 11:17 pm
FDA
Sobi
Kineret
COVID-19
Yes, no, maybe: FDA panel delivers mixed verdict on AstraZeneca's asthma rescue medication
Fierce Biotech
Wed, 11/9/22 - 10:43 am
AstraZeneca
asthma
PT027
FDA
Neurotech's vision loss cell therapy implant hits primary goals in phase 3 trials
Fierce Pharma
Wed, 11/9/22 - 10:36 am
neurotech
cell therapy
FDA
clinical trials
NT-501
central vision loss
Take 2: Teva refiles for approval of long-acting schizophrenia drug months after FDA rejection
Fierce Pharma
Tue, 11/8/22 - 11:06 am
Teva Pharmaceutical
schizophrenia
FDA
mdc-IRM
FDA Cites ‘Uncertainties’ in Veru's COVID-19 Antiviral Data Ahead of Adcomm
BioSpace
Tue, 11/8/22 - 10:57 am
Veru
FDA
antivirals
COVID-19
Key to biosimilar competition will come from interchangeability, FDA officials say
Endpoints
Tue, 11/8/22 - 10:52 am
FDA
biosimilars
interchangeability
BioMarin's hemophilia gene therapy faces further delays over fresh FDA requests
Fierce Biotech
Tue, 11/8/22 - 10:46 am
Biomarin
gene therapy
FDA
hemophilia
Roctavian

Pages