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recent pharma news

Dec 17, 2024

FDA Approves Neurocrine’s CRENESSITY for Congenital Adrenal Hyperplasia; Checkpoint’s UNLOXCYT Approved; MAIA’s THIO Gets Rare Pediatric Disease Designation; JEMPERLI  Receives Breakthrough Therapy for Rectal Cancer; Galderma’s NEMLUVIO Approved for Atopic Dermatitis.

Dec 10, 2024

AbbVie Reveals Phase III TEMPO-2 Trial Positive Topline Results; FDA Accepts GSK’s NUCALA Submission in COPD; Novartis Boosts Huntington’s Disease Development Program with PTC518 In-Licensing; Chimerix to File for Accelerated FDA Approval of Dordaviprone for H3 K27M-Mutant Diffuse Glioma; MeiraGTx Receives FDA RMAT Designation for AAV2-hAQP1 in Grade 2/3 Radiation-Induced Xerostomia Treatment

Dec 03, 2024

FDA Grants Fast Track for Lin BioScience’s LBS-007; Alnylam’s AMVUTTRA sNDA Under Review; FDA Approves RAPIBLYK for Atrial Fibrillation; Applied Therapeutics Receives CRL for Govorestat in Galactosemia; R289 Gets Fast Track for Lower-Risk MDS.

Nov 26, 2024

FDA Grants Orphan Drug Designation for Ractigen’s RAG-21 in ALS; Intellia’s Nexiguran RMAT for ATTR Amyloidosis; FDA Approves Acoramidis for ATTR-CM; Jazz Wins FDA Approval for Ziihera in HER2-Positive Biliary Cancer; J&J Seeks FDA Approval for Subcutaneous TREMFYA in Colitis

Nov 19, 2024

FDA Approves PTC’s AADC Gene Therapy; DUPIXENT sBLA Acceptance for Urticaria; CHMP Recommends TAGRISSO for EGFR Lung Cancer; FDA Approves DANZITEN for CML; Syndax Wins FDA Approval for REVUFORJ in Acute Leukemia

Nov 12, 2024

AUCATZYL Approved for R/R B-ALL; FDA Accepts NDA for Unicycive’s Oxylanthanum Carbonate; AstraZeneca and Amgen Report Positive Results in Chronic Rhinosinusitis; Nipocalimab Granted Breakthrough Designation for Sjögren’s Disease; AbbVie’s Schizophrenia Drug Fails Phase Studies

Nov 05, 2024

Prolong’s PP-007 Fast-Tracked for Stroke; FDA Expands JYLAMVO Pediatric Approval; Corcept’s Cushing’s Drug Shows Positive Phase III Results; ESSA Halts Phase II Study of Masofaniten for Prostate Cancer; SCEMBLIX Approved for Leukemia

Oct 29, 2024

FDA Grants Orphan Status to MDL-101 for LAMA2-CMD; Pfizer’s ABRYSVO Approved for High-Risk Adults (18-59); KIND’s AND017 Gains Orphan Designation for Sickle Cell Disease; HiberCell’s HC-7366 Fast-Tracked for AML; ORLYNVAH Approved for Uncomplicated UTIs

Oct 22, 2024

Gilead and Merck Announce Encouraging Phase II Results of Islatravir and Lenacapavir Combo; REGENXBIO Highlights Positive Data from Phase II ABBV-RGX-314 Wet AMD Study at AAO 2024; FDA Greenlights Astellas’ VYLOY for Advanced Gastric and GEJ Cancer Therapy; Merck’s CAPVAXIVE Vaccine Yields Strong Immune Response in Adults Vulnerable to Pneumococcal Disease; FDA Postpones LUMAKRAS Colorectal Cancer Verdict to Early 2025

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