Pharma News - Chemdiv

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

Simlandi is approved to treat multiple indications, including rheumatoid arthritis and Crohn’s disease.

GSK, pushing back UTI filing by a year, shows antibiotic's gonorrhea potential in phase 3

GSK may have pushed back plans to secure approval for gepotidacin as the first new urinary tract infection (UTI) treatment in 20 years, but fresh phase 3 results have lined up the antibiotic for a...

Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

Jacobio Pharma, a clinical-stage oncology company drugging the undruggable targets, announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C ac...

Cleveland Clinic researchers uncover how virus causes cancer, point to potential treatment

Cleveland Clinic researchers have discovered a key mechanism used by Kaposi's sarcoma-associated herpesvirus (KSHV), also known as human herpesvirus 8 (HHV8), to induce cancer.

BlossomHill secures $100m for cancer discovery programmes

BlossomHill Therapeutics has secured $100m in a Series B financing round, a significant move to progress the development of its programmes targeting cancer and autoimmune diseases.

Does yogurt reduce risk of diabetes? The FDA says it might

Food makers can advertise that regularly eating yogurt may reduce the risk of Type 2 diabetes without objection from the Food and Drug Administration, the agency announced on Friday.

FDA Approves Rybrevant-Chemo Combination for EGFR-Positive Lung Cancer

The Food and Drug Administration approved Rybrevant plus carboplatin and pemetrexed for locally advanced or metastatic non-small cell lung cancer (NSCLC) that has EGFR exon 20 insertion mutations.

FDA Issues Full Response Letter to Cefepime-taniborbactam Agreement

The FDA has issued a Complete Response Letter for the New Drug Application of cefepime-taniborbactam, requesting additional chemistry, manufacturing, and controls data.

Ocugen completes dosing of first cohort in trial of gene therapy for Stargardt disease

Biotechnology company Ocugen announced that dosing is complete in the first cohort of its phase 1/2 GARDian clinical trial of OCU410ST, a modifier gene therapy candidate for treatment of Stargardt...

AbbVie and Tentarix partner to develop oncology and immunology biologics

AbbVie and Tentarix Biotherapeutics have announced a multi-year collaboration aimed at developing biologic candidates in oncology and immunology.

FDA generic drug approvals rose in 2023 in bid for improved access

The FDA's Office of Generic Drugs reported a rise in generic drug approvals, as several first-time generics entered the market.

Cyberattack At UnitedHealth's Change Healthcare Hits US Pharmacies

American Hospital Association or AHA urged healthcare facilities across the United States to disconnect from Change Healthcare.