FDA

Novartis, BeiGene lay out frontline PhIII data for PD-1 drug as second-line PDUFA date looms
Endpoints
Thu, 06/30/22 - 12:11 pm
Novartis
BeiGene
FDA
tislelizumab
gastrointestinal cancer
Pfizer Seeks Full FDA Approval For Covid Antiviral Pill Paxlovid
Forbes
Thu, 06/30/22 - 11:00 am
Pfizer
Paxlovid
COVID-19
FDA
FDA Partially Halts Sanofi’s BTK Inhibitor for Multiple Sclerosis, Myasthenia Gravis
Pharma Live
Thu, 06/30/22 - 10:59 am
Sanofi
multiple sclerosis
myasthenia gravis
FDA
tolebrutinib
clinical trials
clinical hold
Janssen secures FDA breakthrough designation for myeloma therapy
Pharmaceutical Business Review
Thu, 06/30/22 - 10:54 am
JNJ
Janssen
breakthrough therapy
FDA
talquetamab
Multiple Myeloma
relapsed or refractory multiple myeloma
FDA panel recommends altered COVID-19 vaccines to target omicron subvariants
Beckers Hospital Review
Tue, 06/28/22 - 05:57 pm
FDA
vaccines
boosters
Omicron variant
COVID-19
Gilead tries again with twice-yearly HIV drug lenacapavir
Pharmaforum
Tue, 06/28/22 - 05:52 pm
Gilead Sciences
HIV
FDA
lenacapavir
Tracking an FDA advisory panel meeting on updating Covid vaccines
Stat
Tue, 06/28/22 - 10:46 am
COVID-19
vaccines
FDA
Pfizer
Moderna Therapeutics
A decade after its first approval, FDA expands weight loss pill's label for use in adolescents
Endpoints
Tue, 06/28/22 - 10:44 am
Vivus
Qsymia
teens
FDA
obesity
Amidst Legal Battle, BMS' CAR-T Therapy Scores Second FDA Approval
BioSpace
Mon, 06/27/22 - 06:32 pm
Bristol Myers Squibb
CAR-T
Breyanzi
liso-cel
FDA
large B-cell lymphoma
FDA panel to advise on whether — and how — Covid vaccines should be updated
Stat
Mon, 06/27/22 - 10:20 am
FDA
COVID-19
vaccines
FDA accepts Emergent BioSolutions’ anthrax vaccine candidate for review
Pharmaceutical Business Review
Mon, 06/27/22 - 10:16 am
Emergenet BioSolutions
vaccines
anthrax
FDA
AV7909
Sanofi's Top-Selling Drug Just Snagged Another Approval From the FDA
Motley Fool
Mon, 06/27/22 - 10:12 am
Sanofi
Regeneron
FDA
Dupixent
eosinophilic esophagitis
FDA Presses Pause on Astellas' Pompe Disease Therapeutic
BioSpace
Mon, 06/27/22 - 10:07 am
Astellas
Pompe disease
clinical trials
FDA
AT845
BioMarin's hemophilia gene therapy Roctavian wins conditional EU backing amid FDA delay
Fierce Pharma
Mon, 06/27/22 - 10:05 am
Biomarin
Roctavian
EMA
FDA
hemophilia A
valoctocogene roxaparvovec
Pharma-friendly senator calls on FDA for a third time to show patent protections shouldn't be blamed for high drug prices
Endpoints
Fri, 06/24/22 - 10:50 am
FDA
Senate
drug pricing
FDA suspends US testing of Sarepta Duchenne drug over safety concerns
BioPharma Dive
Thu, 06/23/22 - 08:04 pm
FDA
Sarepta Therapeutics
Duchenne Muscular Dystrophy
SRP-5051
Novartis: FDA OKs Tafinlar + Mekinist For Solid Tumors With BRAF V600E Mutation
NASDAQ
Thu, 06/23/22 - 10:57 am
Novartis
FDA
Tafinlar+Mekinist
solid tumors
BRAF V600
FDA approves Ellipses’ application for advanced RET-altered cancer treatment
Pharmaceutical Business Review
Thu, 06/23/22 - 10:52 am
Ellipses Pharma
EP0031
FDA
RET-altered cancer
Appetite for allergies: Alladapt banks $119M to push immunotherapy through trials
Fierce Biotech
Thu, 06/23/22 - 10:43 am
Alladapt Immunotherapeutics
funding
FDA
food allergies
immunotherapy
Krystal Biotech Submits BLA for Rare Skin Disease Treatment
BioSpace
Wed, 06/22/22 - 06:59 pm
Krystal Biotech
B-VEC
FDA
dystrophic epidermolysis bullosa

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