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Global

The latest news from the global pharmaceutical industry

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FDA approves Pfizer’s Beqvez for treatment of haemophilia B

Pfizer has announced that the FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate-to-severe haemophilia B.

4 June 2024Global
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Roche’s HPV self-collection screening option approved by FDA

Roche has announced that the FDA has approved its human papillomavirus (HPV) self-collection solution.

4 June 2024Global
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Amgen’s Imdelltra approved by FDA for extensive-stage small cell lung cancer

Amgen has announced that the FDA has approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer who have had disease progression on or after platinum-based chemotherapy.

4 June 2024Global
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Eko Health’s AI for heart failure detection approved by FDA

Eko Health has announced that the FDA has approved its low ejection fraction (low ef) detection artificial intelligence (AI).

28 April 2024Global
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AstraZeneca & Daiichi Sankyo’s BLA for datopotamab deruxtecan accepted by FDA for breast cancer

AstraZeneca and Daiichi Sankyo have announced that their biologics license application (bla) for datopotamab deruxtecan (dato-dxd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (hr)-positive, her2-negative breast cancer who have had prior systemic therapy for unresectable or metastatic disease.

28 April 2024Global
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Candel Therapeutics’ pancreatic cancer treatment granted ODD by FDA

Candel Therapeutics has announced that the FDA has granted orphan drug designation (ODD) to can-2409, Candel’s immunotherapy candidate, for the treatment of pancreatic cancer.

28 April 2024Global
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FDA accepts GSK’s meningococcal vaccine candidate BLA for review

GSK has announced that the FDA has accepted for review a biologics license application (BLA) for its 5-in-1 meningococcal abcwy (menabcwy) vaccine candidate.

28 April 2024Global
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FDA approves Roche’s Alecensa lung cancer treatment

Roche has announced that the FDA has approved alecensa (alectinib) for the adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (alk)-positive non-small cell lung cancer (nsclc).

28 April 2024Global
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ImmunityBio’s Anktiva bladder cancer treatment approved by FDA

ImmunityBio has announced that the FDA has approved Anktiva (n-803, or nogapendekin alfa inbakicept-pmln) plus bacillus calmette-guérin (bcg) for the treatment of patients with bcg-unresponsive non-muscle invasive bladder cancer (nmibc) with carcinoma in situ (cis), with or without papillary tumours.

28 April 2024Global
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Rezdiffra approved by FDA as first treatment for liver scarring due to fatty liver disease

The FDA has announced that it has approved Rezdiffra (resmetirom) for the treatment of adult patients with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate-to-advanced liver scarring (fibrosis), for use alongside diet and exercise.

7 April 2024Global
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FDA grants IND clearance to Spero Therapeutics’ bacterial infection treatment

Spero Therapeutics has announced that it has gained FDA clearance for the investigational new drug (IND) application to assess SPR206 in a phase 2 clinical study.

7 April 2024Global
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J&J’s Opsynvi approved in US for PAH treatment

Johnson & Johnson (J&J) has announced that the FDA has approved Opsynvi (macitentan and tadalafil) for the chronic treatment of adults with pulmonary arterial hypertension (PAH).

7 April 2024Global