Regen BioPharma's HemaXellerate, a stem cell-derived therapy, has received FDA clearance for a Phase 1 clinical trial initially focused on aplastic anemia.

King's College Hospital will pilot Ondine Biomedical's Steriwave technology as part of a quality improvement initiative to prevent hospital-acquired infections (HAIs).

BioRestorative Therapies reports positive preliminary data from its Phase 2 trial of BRTX-100 for chronic lumbar disc disease (cLDD).

UNITY Biotechnology received FDA guidance suggesting a non-inferiority trial design for UBX1325 (foselutoclax) compared to aflibercept in treating diabetic macular edema (DME).

CytoDyn has received FDA clearance to begin a Phase II oncology trial evaluating leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer.

Alembic Pharmaceuticals has received final USFDA approval for generic Carbamazepine 200 mg tablets, an anticonvulsant used for seizure disorders and neuropathic pain with a US market size of approximately $32 million.

The FDA has accepted Milestone Pharmaceuticals' NDA for Cardamyst (etripamil) nasal spray, a potential treatment for paroxysmal supraventricular tachycardia (PSVT).

KalVista Pharmaceuticals' NDA for sebetralstat, an oral plasma kallikrein inhibitor, has been accepted by the FDA for on-demand treatment of hereditary angioedema (HAE) attacks.

Longboard Pharmaceuticals' bexicaserin demonstrated a 57.7% median reduction in countable motor seizures over nine months in DEE patients.

The FDA has accepted KalVista's New Drug Application for sebetralstat, an oral treatment for hereditary angioedema (HAE) attacks, with a PDUFA date set for June 17, 2025.

Agios Pharmaceuticals is developing Tebapivat (AG-946), an oral PKR activator, targeting multiple hemolytic anemic conditions including sickle cell disease and PK deficiency.

Eton Pharmaceuticals has launched Galzin (zinc acetate) capsules, the only FDA-approved zinc therapy for Wilson disease maintenance treatment, offering improved access through their specialty pharmacy network.

Madrigal Pharmaceuticals' Rezdiffra (resmetirom) shows significant improvements in emotional well-being and health distress in MASH/NASH patients.

Paratek Pharmaceuticals is presenting new data on NUZYRA (omadacycline) at IDWeek 2024, highlighting its potential in treating various serious infections.

Gan & Lee Pharmaceuticals' GZR18 injection demonstrated superior HbA1c and body weight reduction compared to semaglutide in T2D patients over 24 weeks.

Health Canada has approved Daybue (trofinetide) for treating Rett syndrome in patients aged two years and older, marking the first approved treatment for the condition in Canada.

Alkeus Pharmaceuticals announced the presentation of clinical study results for oral gildeuretinol in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Regeneron's combination therapy, pozelimab and cemdisiran, demonstrated significant efficacy in a Phase 3 trial for Paroxysmal Nocturnal Hemoglobinuria (PNH).

Woolsey Pharmaceuticals' BRAVYL (oral fasudil) significantly reduced TDP-43 aggregation and cytoplasmic redistribution in ALS patients after six months of treatment.

Centessa Pharmaceuticals appointed Stephen Kanes as Chief Medical Officer, leveraging his 30+ years of experience in neuroscience and drug development.