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Sanofi extends collaboration with Genedata for Pharmaceutical Development & Manufacturing Science

Latest FDA approvals update...
Jul 16

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

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

Moleculin Announces Annamycin Receives FDA Orphan Drug Designation for Soft Tissue Sarcomas

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 ...
Dec 30

Roche announces FDA approval of Xofluza

Xofluza for the prevention of influenza following contact with an infected person...
Nov 27

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

Regeneron’s Antibody cocktail REGN-EB3 (Inmazeb) is first FDA-Approved treatment for Ebola

First FDA approved antibody treatment for Ebola...
Oct 19

AbbVie received US FDA approval for the treatment of acute myeloid leukemia

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Oct 17

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

Gyroscope Therapeutics Granted FDA Fast Track Designation for GT005

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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

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

FDA clears blood test for Novel Allergic Sensitization in red meat

Thermo Fisher Scientific's ImmunoCAP test helps clinicians pinpoint a potentially fatal allergy often resulting from tick bites...
Jul 27

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