After Initial Skepticism FDA’s Adcomm Backs Amylyx’s Amyotrophic Lateral Sclerosis Hopeful
The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted (7 yes and 2 no) that the…
Regeneron Gains As New Data Favors Higher Dose Of Flagship Eye Disease Drug
Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) two pivotal trials evaluating aflibercept 8 mg with 12- and 16-week dosing regimens met the primary…
NexImmune Shares Jump On Immunotherapy Pact For Rare Cancers, Autoimmune Disorders
Selexis SA and NexImmune Inc (NASDAQ:NEXI) have agreed to develop cell lines targeting rare cancers and autoimmune diseases and to advance two HLAs…
Mirati’s Adagrasib Shows Promising Efficacy In KRAS Mutated Colorectal Cancer
Mirati Therapeutics Inc (NASDAQ:MRTX) announced results from the KRYSTAL-1 Phase 1/2 study of adagrasib with or without cetuximab in patients with…
Amryt Secures UK Regulatory Nod And Orphan Disease Status For Skin Disorder Candidate
The Medical Healthcare & Products Regulatory Agency (MHRA) has granted Marketing Authorisation Approval (MAA) and Orphan Disease Designation (ODD) for Amryt’s (NASDAQ: AMYT) lead candidate Filsuvez for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in
Internationally Published, Head-To-Head Data From India Of Petros Pharmaceuticals’ STENDRA Tablets Reported Improvement In Erectile Function Also Showed Secondary Endpoints
Data Published in the "International Journal of Urology" Also Showed Secondary Endpoints, Such as Onset of action in 15 Minutes and Percentage of Patients Reaching Normal Erectile Function According to the
Eli Lilly Says Lebrikizumab Dosed Every Four Weeks Maintained Durable Skin Clearance in Lilly’s Phase 3 Monotherapy Atopic Dermatitis Trials
New, late-breaking data show lebrikizumab responders reported long-lasting results at one year of treatment across measures of improvement in skin clearance, itch and disease extent and severity
Results suggest less
Ocuphire Pharma Announces Last Patient Completes Final Visit In ZETA-1 Phase 2b 24-Week Trial Of Oral APX3330 In Diabetic Retinopathy
Top-line Results are Expected in 4Q 2022
Interim Masked Safety Results Seen Demonstrate Favorable Safety and Tolerability Profile, Consistent with 11 Prior Trials of APX3330
Oral APX3330 has the Potential to Serve a
Amryt Receives Marketing Authorisation Approval And Orphan Drug Designation For Filsuvez In Great Britain
Amryt (NASDAQ:AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that the Medical Healthcare &
Revance Announces FDA Approval of DAXXIFY For Injection, A Peptide-Formulated Neuromodulator With Long-Lasting Results
Approved label includes full 36-week efficacy data from Phase 3 SAKURA clinical program, positioning DAXXIFY™ as the first and only long-acting neuromodulator that demonstrates a median duration of six months and