You are here

FDA

Bristol Myers Squibb's CAR-T liso-cel wins long-delayed FDA nod

Bristol Myers Squibb's CAR-T liso-cel wins long-delayed FDA nod

Fierce Pharma

Bristol-Myers Squibb

Flag link:

Woodcock: FDA plans guidance to address new COVID-19 variants

Woodcock: FDA plans guidance to address new COVID-19 variants

RAPS.org

drug developments

Flag link:

PTC aims again for FDA review of Duchenne drug despite latest miss

PTC aims again for FDA review of Duchenne drug despite latest miss

BioPharma Dive

PTC Therapeutics

Duchenne Muscular Dystrophy

Flag link:

FDA weighs tighter restrictions for Pfizer's Xeljanz on the heels of safety red flags

FDA weighs tighter restrictions for Pfizer's Xeljanz on the heels of safety red flags

Fierce Pharma

Flag link:

Novavax Initiates Rolling Review for Vaccine & Other COVID News

Novavax Initiates Rolling Review for Vaccine & Other COVID News

BioSpace

Flag link:

FDA arranges Feb. 26 AdComm to discuss J&J COVID-19 vaccine EUA

FDA arranges Feb. 26 AdComm to discuss J&J COVID-19 vaccine EUA

Fierce Biotech

advisory panels

Emergency Use Authorization

Flag link:

FDA holds back from action over Xeljanz safety study FDA holds back from action over Xeljanz safety study

FDA holds back from action over Xeljanz safety study FDA holds back from action over Xeljanz safety study

Pharmaforum

rheumatoid arthritis

Flag link:

J&J asks FDA for emergency clearance of coronavirus vaccine

J&J asks FDA for emergency clearance of coronavirus vaccine

BioPharma Dive

Emergency Use Authorization

Flag link:

FDA Approves First Prosthetic Implant for Above-Knee Amputees

FDA Approves First Prosthetic Implant for Above-Knee Amputees

Medical Devices and Diagnostics Industry

OPRA Implant System

above-knee amputees

Flag link:

FDA appoints first medical device cybersecurity chief

FDA appoints first medical device cybersecurity chief

Medtech Dive

Flag link:

AbbVie's immunology newbies Skyrizi and Rinvoq pick up the slack from declining Humira, but safety questions dog execs

AbbVie's immunology newbies Skyrizi and Rinvoq pick up the slack from declining Humira, but safety questions dog execs

Fierce Pharma

Flag link:

FDA Approves Merck KGaA's Tepmetko for Aggressive Lung Cancer

FDA Approves Merck KGaA's Tepmetko for Aggressive Lung Cancer

BioSpace

metastatic non-small cell lung cancer

Flag link:

FDA Hit Record Drug and Biologic Approvals in 2020, Despite Ongoing Pandemic

FDA Hit Record Drug and Biologic Approvals in 2020, Despite Ongoing Pandemic

BioSpace

Flag link:

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

Drug Patent Watch

Flag link:

Bristol Myers Squibb turns in priority review voucher for supplemental indication on an old Celgene drug

Bristol Myers Squibb turns in priority review voucher for supplemental indication on an old Celgene drug

Endpoints

Bristol-Myers Squibb

ulcerative colitis

priority review

Flag link:

Novavax and Johnson & Johnson Seek Regulatory Approval for COVID-19 Vaccines After Posting Promising Efficacy Data

Novavax and Johnson & Johnson Seek Regulatory Approval for COVID-19 Vaccines After Posting Promising Efficacy Data

Xtalks

Flag link:

Durect's non-opioid painkiller brushes aside checkered past, gaining FDA approval in shoulder surgeries

Durect's non-opioid painkiller brushes aside checkered past, gaining FDA approval in shoulder surgeries

Endpoints

non-opioid pain treatments

Flag link:

FDA Action Alert: Adamas, Mallinckrodt and Merck

FDA Action Alert: Adamas, Mallinckrodt and Merck

BioSpace

Adamas Pharmaceuticals

triple negative breast cancer

Flag link:

Incyte makes bid to join the checkpoint inhibitor club

Incyte makes bid to join the checkpoint inhibitor club

Pharmaforum

Flag link:

Here’s Why the Approval of Lupkynis Has Biotech Investors Buzzing

Here’s Why the Approval of Lupkynis Has Biotech Investors Buzzing

Xtalks

Aurinia Pharmaceuticals

lupus nephritis

Flag link:

Pages