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TherapeuticsMD’s therapy for menopause-related condition gets approval

TherapeuticsMD Inc. won its first-ever FDA approval as the U.S. drug regulator cleared the women’s healthcare company’s hormone therapy – after rejecting it one year earlier – for a painful condition triggered by menopause.

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FDA Clears Sun Pharma’s Yonsa for Prostate Cancer

Sun Pharmaceutical Industries received approval from the U.S. Food and Drug Administration for Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer.

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AstraZeneca wins U.S. approval for 1st-line use of lung cancer drug

U.S. regulators expanded use of AstraZeneca’s lung cancer drug Tagrisso to include initial treatment of patients with a specific genetic mutation.

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Eisai Submits Fycompa Pediatric Indications to FDA

Eisai Inc. submitted a supplemental New Drug Application for priority review to the U.S. FDA for the company’s antiepileptic drug Fycompa (perampanel) CIII as monotherapy and adjunctive use.

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FDA approves Toujeo Max SoloStar

The U.S. Food and Drug Administration approved Sanofi’s Toujeo (insulin glargine 300 Units/mL) Max SoloStar, the highest capacity long-acting insulin pen that will be available on the market.

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FDA Approves Multi-Drug Resistant HIV-1 Treatment

Shares of Theratechnologies and TaiMed Biologics jumped after the U.S. Food and Drug Administration green lit Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.

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FDA Grants Sunovion’s Latuda Expanded Approval

The FDA approved a supplemental NDA that expands the use of Sunovion’s Latuda to include treating major depressive episode associated with bipolar I disorder in pediatric patients.

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U.S. FDA approves Gilead triple HIV drug

The FDA approved Biktarvy, Gilead’s once-daily, triple-combo tablet for treating HIV infection, paving the way for the biotech company to capture more of the multibillion-dollar HIV drug market.

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Ferring’s Zomacton Receives FDA Approval to Treat Growth Hormone Deficiency in Adults

Ferring Pharmaceuticals Inc. announced that the U.S. FDA approved Zomacton (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.

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FDA Approves Trulance for IBS-C in Adults

Synergy Pharmaceuticals Inc. announced that the U.S. FDA approved Trulance (plecanatide) 3-mg tablet for the once-daily treatment of irritable bowel syndrome with constipation in adults.

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