FDA

FDA clears Roche’s Susvimo implant for eye disease wet AMD
Pharmaforum
Sun, 10/24/21 - 10:38 pm
Roche
Genentech
FDA
Susvimo
wet age-related macular degeneration
FDA scientists say benefits of Pfizer Covid-19 vaccine ‘clearly outweigh’ the risks for children ages 5 to 11
Stat
Sun, 10/24/21 - 10:30 pm
FDA
Pfizer
vaccines
pediatric
COVID-19
Regulatory rejection flurry does not make a storm
EP Vantage
Fri, 10/22/21 - 12:07 pm
FDA
complete response letter
regulatory
Pfizer pitches its Covid-19 vaccine for younger children ahead of adcomm next week
Endpoints
Fri, 10/22/21 - 11:28 am
Pfizer
FDA
COVID-19
vaccines
pediatric
Senators back FDA's plan to require mandatory prescriber education for opioids
Endpoints
Thu, 10/21/21 - 11:14 pm
FDA
Senate
opioids
opioid education
opioid crisis
FDA authorizes additional Moderna, J&J shots, broadening booster rollout
BioPharma Dive
Wed, 10/20/21 - 06:58 pm
FDA
Moderna Therapeutics
JNJ
boosters
vaccines
COVID-19
FDA slaps clinical hold on AstraZeneca cancer drug amid heart safety scare in combo test
Fierce Biotech
Wed, 10/20/21 - 06:54 pm
AstraZeneca
clinical trials
FDA
clinical hold
AZD5991
AML
FDA shoots down a biotech’s last-stand patient pitch after faulting data
Endpoints
Wed, 10/20/21 - 10:29 am
Stealth BioTherapeutics
FDA
Barth Syndrome
elamipretide
FDA will allow mixing and matching doses for COVID-19 boosters
Beckers Hospital Review
Tue, 10/19/21 - 11:03 pm
FDA
vaccines
COVID-19
boosters
Biogen, Sage plot 2022 filing for zuranolone approval, furthering turnaround of depression drug
Fierce Biotech
Tue, 10/19/21 - 11:54 am
Biogen
SAGE Therapeutics
zuranolone
FDA
clinical depression
Boehringer wins 'interchangeable' status for Humira copy, strengthening competitive threat
BioPharma Dive
Mon, 10/18/21 - 10:55 pm
Boehringer Ingelheim
AbbVie
Humira
interchangeable biosimilars
biosimilars
Cyltezo
FDA
Third time's the charm: Adamis nabs approval of high-dose naloxone injection after two CRLs
Endpoints
Mon, 10/18/21 - 10:47 pm
Adamis Pharmaceuticals
FDA
Naloxone
opioid overdose
FDA declines to approve United-MannKind's lung disease therapy
Yahoo/Reuters
Mon, 10/18/21 - 10:42 pm
MannKind
United Therapeutics
Tyvaso
FDA
PAH
FDA OKs an inhaled version of smoking cessation drug Chantix — for a common eye disease
Endpoints
Mon, 10/18/21 - 11:57 am
Oyster Point Pharma
Tyrvaya
FDA
dry eye disease
Chantix
FDA rejects Omeros transplant drug over difficulties estimating its effect
Fierce Biotech
Mon, 10/18/21 - 11:14 am
FDA
organ transplant
stem cells
Omeros
Esperion gets out the budget ax, chopping 170 staffers as its big drug launch sputters
Endpoints
Mon, 10/18/21 - 11:12 am
Esperion Therapeutics
layoffs
FDA
Nexletol
bempadoic acid
Revance's Botox rival turned away by FDA after inspectors flagged manufacturing 'deficiencies'
Fierce Pharma
Mon, 10/18/21 - 11:10 am
Revance Therapeutics
FDA
daxibotulinumtoxinA
Botox
Daxi
AbbVie
Medtronic misses bid for early FDA OK in renal denervation, stock slides
Medtech Dive
Mon, 10/18/21 - 11:05 am
devices
Medtech
Medtronic
FDA
renal denervation
clinical trials
hypertension
Roche scores adjuvant lung cancer approval for Tecentriq
Pharmaforum
Mon, 10/18/21 - 11:00 am
Roche
Tecentriq
FDA
non-small cell lung cancer
Califf re-joining FDA would be positive for industry; analyst
Pharmaforum
Sun, 10/17/21 - 11:02 pm
FDA
Joe Biden
regulatory
Robert Califf

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