AstraZeneca gets FDA approval for PNH drug Voydeya - MSN

Merck gets U.K. approval for sotatercept for PAH - MSN

Pfizer Secures Approval for Hemophilia Drug Hympavzi in the EU - MSN

Elite Pharmaceuticals Gains FDA Approval for Generic Vyvanse

Elite Pharmaceuticals received FDA approval for its Abbreviated New Drug Application (ANDA) for a generic version of Vyvanse (Lisdexamfetamine Dimesylate).
The generic drug will be available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules, indicated for ADHD treatment.

Elite Pharmaceuticals Gains FDA Approval for Generic Vyvanse

Elite Pharmaceuticals received FDA approval for its Abbreviated New Drug Application (ANDA) for a generic version of Vyvanse (Lisdexamfetamine Dimesylate).
The generic Lisdexamfetamine Dimesylate capsules will be available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

Elite Pharmaceuticals Receives FDA Approval for Generic Vyvanse

Elite Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for a generic version of Vyvanse (Lisdexamfetamine Dimesylate).
The generic Vyvanse will be available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules, indicated for ADHD treatment.

FDA Approves Pfizer's Hympavzi for Hemophilia A and B

The FDA has approved Hympavzi (marstacimab-hncq), a once-weekly subcutaneous injection, for hemophilia A and B to prevent or reduce bleeding episodes.
Hympavzi is the first anti-tissue factor pathway inhibitor (anti-TFPI) approved in the U.S. for hemophilia A or B, offering a new mechanism of action.

EC approves Daiichi Sankyo's Vanflyta for acute myeloid leukaemia - MSN

FDA Approves Pavblu, Fifth Biosimilar to Eylea, for Retinal Conditions

The FDA has approved Pavblu (aflibercept-ayyh) as a biosimilar to Eylea (aflibercept) for treating retinal conditions..
Pavblu's approval was based on a Phase 3 study demonstrating similar safety and efficacy to Eylea in patients with wet AMD.

FDA Approves Voquezna (vonoprazan) for Heartburn Relief in Non-Erosive GERD

The FDA has approved Voquezna (vonoprazan) 10 mg tablets for heartburn relief associated with Non-Erosive GERD in adults, marking a new option for millions.
Voquezna demonstrated a significant reduction in heartburn episodes in a Phase 3 trial, offering more 24-hour heartburn-free days compared to placebo.

AstraZeneca's Voydeya Approved for PNH, Merck Advances KRAS Inhibitor

The FDA has approved AstraZeneca's Voydeya (danicopan) as an add-on therapy for extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH).
Merck's oral KRAS G12C inhibitor candidate, MK-1084, has entered phase III development for first-line treatment of metastatic non-small cell lung cancer (NSCLC).