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Investigation finds nearly half of drugs granted FDA ‘fast track’ approval lack proven clinical benefit

Process plagued by missing efficacy data and questionable evidence with standards of evidence being too low ...
Aug 02

FDA Clearance of IND for FPI-1966, Radiopharmaceutical for Head and Neck and Bladder Cancers Expressing FGFR3

Fusion Pharmaceuticals Announces FDA Clearance of IND for FPI-1966 ...
Jul 30

FDA Clearance of IND for FPI-1966, Radiopharmaceutical for Head and Neck and Bladder Cancers Expressing FGFR3

Fusion Pharmaceuticals Announces FDA Clearance of IND for FPI-1966 ...
Jul 30

FDA Grants Alkeus Pharmaceuticals Breakthrough Therapy Designation for ALK-00 ; Stargardt Disease

Latest FDA news update...
Jul 16

Sanofi extends collaboration with Genedata for Pharmaceutical Development & Manufacturing Science

Latest FDA approvals update...
Jul 16

U.S. FDA approves finerenone for the treatment of patients with chronic kidney disease associated with type 2 diabetes

Finerenone has also been submitted for marketing authorization in the European Union (EU) and in China...
Jul 12

Immutep receives FDA and IRB approval in the US for Phase IIb TACTI-003 trial in HNSCC

Immutep was granted Fast Track designation for efti to treat 1st line HNSCC patients by the US FDA in early April 2021. ...
Jul 12

FDA issues Actemra drug for COVID under Emergency Use Authorization (EUA)

The drug, Actemra (tocilizumab) has shown efficacy in treating COVID patients with better results by reducing the death and mortality rate along with complications. FDA ...
Jun 25

Roche SARS-CoV-2 molecular test granted first FDA Emergency Use Authorization for PCR testing for Coronavirus

Roche SARS-CoV-2 molecular test for PCR testing is effective for both symptomatic and asymptomatic Covid individuals ...
Jun 22

Bioheng Biotech received Orphan Drug Designation from the U.S. FDA for the treatment of T-ALL.

New approval for treating leukomia...
Jun 22

Novartis receives FDA approval 177Lu-PSMA-617 for metastatic castration resistant prostate cancer

FDA breakthrough therapy for Novartis metastatic prostate cancer drug ...
Jun 21

FDA grants accelerated approval for Alzheimer’s Disease

FDA shows hope to Alzheimer’s Disease patients this year. The drug Aduhelm may provide a sigh of relief to the patients suffering from Alzheimer’...
Jun 09

FDA authorizes monoclonal antibody therapy for emergency use in some patients 12 and older

The authorization is specifically for those with mild-to-moderate Covid-19, who are at risk of getting much sicker...
May 27

FDA Approves GlaxoSmithKline's immunotherapy for Endometrial Cancer with specific biomarker

GSK gets FDA nod for Jemperli indicated for endometrial cancer...
Apr 26

GSK and Vir Biotechnology requests emergency use authorization to FDA for VIR-7831 for treatment of COVID-19

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE ...
Mar 27

GSK and Vir Biotechnology requests emergency use authorization to FDA for VIR-7831 for treatment of COVID-19

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE ...
Mar 27

FDA approves new indication for drug to treat Neurogenic Detrusor Overactivity in pediatric Patients

NDO is a dysfunction of the bladder that results from congenital conditions...
Mar 26

Precigen Receives FDA Orphan Drug Designation for PRGN-2012 Adenoverse

The drug is used for immunotherapy in patients with Recurrent Respiratory Papillomatosis (RRP)...
Mar 20

BioXcel Therapeutics receives FDA Breakthrough Therapy Designation for BXCL501 for the acute treatment of Dementia

Latest FDA approvals update...
Mar 16

Strides receives USFDA approval for Ibuprofen OTC Oral Suspension

...
Feb 24

BeiGene reports FDA approval for Brukinsa(Zanubrutinib )

Brukisa is indicated for the treatment of adult patients with Waldenström’s Macroglobulinemia ...
Feb 19

Lupin Launches Posaconazole Delayed-Release Tablets

Lupin & its AET Pharma US Inc. (part of Tiefenbacher Group) received an approval for its ANDA from the USFDA...
Feb 17

Forge Biologics receives USFDA fast track, orphan drug, and rare pediatric disease designations

Forge Biologics receives FDA fast track, orphan drug, and rare pediatric disease designations for FBX-101 gene therapy for patients with krabbe disease ...
Feb 17

Sirnaomics announces first patient dosed In phase 2a study of STP705

The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA...
Jan 18

Janssen received U.S. FDA approval for DARZALEX FASPRO

Genmab announces that Janssen has been Granted U.S. FDA Approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for Patients with Newly Diagnosed Light-chain (...
Jan 16

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