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Sarepta shares sink 14% after shock FDA rejection

Shares of Sarepta Therapeutics Inc. plunged 14 percent after the U.S. health regulator, in an unexpected move, declined to approve the drugmaker’s newest treatment for a muscle-wasting disorder.

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First Antibiotic With New Mechanism of Action Approved in Almost 20 Years

The U.S. FDA gave Nabriva Therapeutics a thumbs-up for the company’s oral and intravenous formulations of Xenleta (lefamulin) to treat community-acquired bacterial pneumonia in adults.

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FDA Approves AbbVie’s RA Drug Rinvoq

AbbVie’s Rinvoq was approved by the FDA for treating adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate.

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Shriners Hospitals for Children Announces New Medical Device for Scoliosis Treatment Approved by FDA

A new medical device for treating scoliosis – curvature of the spine – received FDA approval, providing an alternative that both corrects the curve and maintains flexibility in the spine.

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FDA approves Celgene’s bone marrow cancer drug

The U.S. Food and Drug Administration approved Celgene Corp.’s Inrebic to treat certain rare forms of bone marrow cancer called myelofibrosis.

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FDA approves Roche’s cancer drug Rozlytrek

The FDA approved Roche’s personalized cancer treatment Rozlytrek, which targets tumors with specific genetic mutations, irrespective of where in the body the disease started.

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FDA Approves First Non-Controlled Substance Treatment for Narcolepsy

Harmony Biosciences snagged approval from the U.S. FDA for the company’s first commercial product, a treatment for narcolepsy.

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U.S. FDA proposes new health warnings on cigarette packs, advertisements

The FDA proposed new health warnings for cigarette packages and ads due to small size and lack of an image in current warnings.

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U.S. FDA approves TB Alliance’s treatment for drug-resistant tuberculosis

The U.S. Food and Drug Administration approved TB Alliance’s treatment for drug-resistant tuberculosis as part of a three-drug combination regimen called BPaL.

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Calquence Earns Breakthrough Therapy Designation

AstraZeneca’s BTK inhibitor Calquence won Breakthrough Therapy Designation from the U.S. FDA as a monotherapy treatment for patients with chronic lymphocytic leukemia (CLL).

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