Latest pharma news
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
FDA Grants Orphan Drug Status to MDL-101 for LAMA2-CMD Treatment Modalis Therapeutics Corporation has received Orphan Drug Designation (ODD) from the FDA for MDL-101, its promising treatment for congenital muscular dystrophy type 1A (LAMA2-CMD). This designation is a significant step, aimed at fostering the deve...
Read More...
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
Gilead and Merck Reports Phase II Data Showing that Switching to a Once-Weekly Oral Combination of Islatravir and Lenacapavir Maintained Viral Suppression in Adults Through 48 Weeks Gilead Sciences, Inc. and Merck have shared new findings from a Phase II clinical trial assessing the experimental combination of i...
Read More...
Oct 15, 2024
Astellas & AviadoBio’s Exclusive Deal for AVB-101; GSK’s Depemokimab Shows Positive Results for Nasal Polyps; Lilly’s Mirikizumab Outperforms Ustekinumab in Crohn’s Study; TREMFYA Delivers Strong Results in Crohn’s & Colitis; ENHERTU Approved in China for HER2-Mutant NSCLC.
Astellas & AviadoBio Sign Exclusive Deal for Gene Therapy AVB-101 in Frontotemporal Dementia AviadoBio Ltd. and Astellas Pharma Inc. have announced a strategic partnership under an exclusive option and license agreement for AVB-101, an investigational AAV-based gene therapy currently in Phase I/II developmen...
Read More...
Oct 08, 2024
OPDIVO Approved for Resectable NSCLC; Palvella Gets $2.6M FDA Grant; First Patient Dosed in UGN-103 Bladder Cancer Trial; Recordati Acquires ENJAYMO for $825 Million; AIRSUPRA Reduces Severe Asthma Exacerbations
FDA Approves Perioperative OPDIVO Plus Chemotherapy for Resectable NSCLC The FDA has granted approval to Bristol Myers Squibb’s OPDIVO (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC), specifically targeting tumors that are 4 cm or larger or node-positive and hav...
Read More...
Oct 01, 2024
IntraBio’s AQNEURSA Niemann-Pick Disease Approval; FDA Approves Novel Schizophrenia Drug After 35 Years; Selpercatinib Gets FDA Nod for RET-Mutated MTC; DUPIXENT Receives First-Ever COPD Approval; Pfizer Withdraws OXBRYTA for Sickle Cell Disease from Global Market
IntraBio's AQNEURSA Receives Historic FDA Approval for Niemann-Pick Disease Type C Treatment IntraBio Inc. has received approval from the FDA for AQNEURSA (levacetylleucine), marking a significant milestone in the treatment of neurological manifestations of Niemann-Pick disease type C in both adults and pe...
Read More...
Sep 24, 2024
Zevra’s MIPLYFFA Niemann-Pick Disease Approval; FASENRA Approved for Eosinophilic Granulomatosis; Sanofi’s SARCLISA Gets Multiple Myeloma Approval; RYBREVANT Combo Gets FDA Nod for EGFR Lung Cancer; UCB’s BIMZELX Receives Multiple Approval from the FDA
FDA Greenlights Zevra Therapeutics’ MIPLYFFA for Niemann-Pick Disease Type C Zevra Therapeutics, Inc. has announced that the FDA has approved MIPLYFFA (arimoclomol) capsules as the first oral treatment for Niemann-Pick disease type C. Indicated for use alongside miglustat, MIPLYFFA is intended for both adult and...
Read More...
Sep 17, 2024
Johnson & Johnson’s TREMFYA Approved for Ulcerative Colitis; Roche’s Tecentriq Hybreza Approved as Subcutaneous Anti-PD-(L)1; OCREVUS ZUNOVO Receives Twice-a-Year Multiple Sclerosis Injection Approval; Lilly’s EBGLYSS Greenlit for Moderate-to-Severe Atopic Dermatitis; DUPIXENT Approved for Adolescents with Chronic Rhinosinusitis
TREMFYA Approved for Moderately to Severely Active Ulcerative Colitis Johnson & Johnson announced that the FDA has approved TREMFYA (guselkumab) for treating adults with moderately to severely active ulcerative colitis. TREMFYA is the first fully human, dual-acting monoclonal antibody that blocks IL-23 and b...
Read More...
Sep 10, 2024
Biogen’s SPINRAZA Phase II/III Trial Results; Travere’s FILSPARI FDA Approval; GSK’s NUCALA Succeeds in COPD Trial; Summit’s NSCLC Win Over KEYTRUDA Raises Caution; FDA Lifts Hold on RZ358 for Congenital Hyperinsulinism
Biogen's Higher SPINRAZA Dose Shows Improved Efficacy in Phase II/III Trial A trial studying a higher dose of Biogen’s spinal muscular atrophy drug SPINRAZA (nusinersen) has met the primary endpoint in a cohort of infants with SMA. The Phase II/III DEVOTE study, which included 145 patients across various ages an...
Read More...
Sep 03, 2024
Bayer Phase III NSCLC Trial; D&D Pharmatech Gets FDA Nod for GLP-1R Agonist in Multiple Scletosis; Merck Halts Two KEYTRUDA Trials; Novartis Expands LEQVIO After Phase III Success; Alnylam Reports Strong Phase III Data for Vutrisiran
Bayer Starts Phase III Trial In Non-Small Cell Lung Cancer (NSCLC) Bayer has officially enrolled the first patient in the global Phase III SOHO-02 trial, which will evaluate the efficacy and safety of BAY 2927088 as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with activating HER2 mutat...
Read More...
Aug 27, 2024
Merck’s WINREVAIR™ EU Approval; BALVERSA for Urothelial Carcinoma; Novartis and Versant’s Borealis Launched; Moderna’s RSV mRESVIA® EU Approval; FDA Nods RYBREVANT® and LAZCLUZE™ for EGFR-mutated Lung Cancer
Merck’s WINREVAIR Approved by the European Commission for PAH in Adults with Functional Class II-III Merck has secured European Commission (EC) approval for WINREVAIR™ (sotatercept), marking it as the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH) approved across all 27 EU me...
Read More...
-Agonist.png "Toll-like Receptors Agonist")
