Search Results

You searched for : FDAApprovalNews

	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
	Unichem gets US FDA approval for Atenolol and Chlorthalidone Tablets Another ANDA approval for Unichem... Nov 30
	Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE (setmelanotide) First-ever Therapy for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency... Nov 28
	Alembic Pharmaceuticals receives USFDA Tentative Approval for Palbociclib Capsules for Breast Cancer Alembic now has a total of 135 ANDA approvals (117 final approvals and 18 tentative approvals) from USFDA.... Nov 10
	BioXcel Therapeutics FDA Clearance of IND for Phase 2 Trial with BXCL501 BXCL50 is indicated for the treatment of agitation associated with Delirium... Oct 27
	Protagonist Therapeutics receives orphan drug designation from the EMA for PTG-300 in polycythemia vera Protagonist Therapeutics has previously received orphan drug designation for the treatment of polycythemia vera from US FDA... Oct 22
	Astellas Pharma received US FDA approval for the treatment of primary mitochondrial myopathies U.S. FDA grants fast track designation for ASP0367/MA-0211, a selective PPARÎ´ modulator being developed for the treatment of primary mitochondrial myopathies ... Oct 21
	Ezra receives US FDA clearance for prostate cancer artificial intelligence Ezra's Prostate AI is the first to ever be cleared by the FDA for prostate and lesion segmentation using AI ... Oct 20
	Regeneronâ€™s Antibody cocktail REGN-EB3 (Inmazeb) is first FDA-Approved treatment for Ebola First FDA approved antibody treatment for Ebola... Oct 19
	Bristol Myers Squibbs get FDA approval for Opdivo and Yervoy : Malignant Pleural Mesothelioma Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA ... Oct 03
	FDA grants IND Approval for Stemedica's itMSC Therapy for COVID-19 Patients The study will enrol up to 40 patients into two cohorts, randomized 1:1 to receive the active study drug plus standard treatment or placebo... Sep 29
	FDA Grants AT-007 Pediatric Rare Disease Designation and Orphan Designation for treatment of PMM2-CDG PMM2-CDG is a debilitating rare disease causes multiple organ failure and severe disability, resulting in approximately 20% mortality in the first four years of ... Sep 26
	Genocea announces FDA acceptance of GEN-011 IND Application ... Sep 23
	Gyroscope Therapeutics Granted FDA Fast Track Designation for GT005 ... Sep 23
	Preparation products of Yiling Pharma approved by FDA for launch in the US market Receives ANDA for Lisinopril and Acylovir tablets... Sep 21
	Roche receives FDA approval for CINtec PLUS Cytology test in preventing cervical cancer Cervical cancer detection gets new tests for early diagonosis... Sep 18
	Vaxart announces FDA clearance of IND application for oral COVID-19 Vaccine Oral Covid vaccine gains ground... Sep 18
	LuminUltra submits COVID-19 clinical diagnostic testing kit for regulatory authorization in U.S., Canada End-to-end solution and components offer flexibility to testing facilities, meeting high-volume demand and significantly boosting global testing capacity ... Sep 16
	FDA approves GSK and Innoviva's Trelegy Ellipta for the treatment of both asthma and COPD in the US The FDA-approved strength for both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. ... Sep 14
	Junshi Biosciences receives FDA Breakthrough Therapy Designation for Toripalimab Major breakthrough for treatment of Nasopharyngeal Carcinomar ... Sep 11
20 Matching result(s) found!

-Advertisements-

Search Results

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

Unichem gets US FDA approval for Atenolol and Chlorthalidone Tablets

Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE (setmelanotide)

Alembic Pharmaceuticals receives USFDA Tentative Approval for Palbociclib Capsules for Breast Cancer

BioXcel Therapeutics FDA Clearance of IND for Phase 2 Trial with BXCL501

Protagonist Therapeutics receives orphan drug designation from the EMA for PTG-300 in polycythemia vera

Astellas Pharma received US FDA approval for the treatment of primary mitochondrial myopathies

Ezra receives US FDA clearance for prostate cancer artificial intelligence

Regeneronâ€™s Antibody cocktail REGN-EB3 (Inmazeb) is first FDA-Approved treatment for Ebola

Bristol Myers Squibbs get FDA approval for Opdivo and Yervoy : Malignant Pleural Mesothelioma

FDA grants IND Approval for Stemedica's itMSC Therapy for COVID-19 Patients

FDA Grants AT-007 Pediatric Rare Disease Designation and Orphan Designation for treatment of PMM2-CDG

Genocea announces FDA acceptance of GEN-011 IND Application

Gyroscope Therapeutics Granted FDA Fast Track Designation for GT005

Preparation products of Yiling Pharma approved by FDA for launch in the US market

Roche receives FDA approval for CINtec PLUS Cytology test in preventing cervical cancer

Vaxart announces FDA clearance of IND application for oral COVID-19 Vaccine

LuminUltra submits COVID-19 clinical diagnostic testing kit for regulatory authorization in U.S., Canada

FDA approves GSK and Innoviva's Trelegy Ellipta for the treatment of both asthma and COPD in the US

Junshi Biosciences receives FDA Breakthrough Therapy Designation for Toripalimab