Ad Header



The Pulse of the Pharmaceutical Industry

  • Filter By Category

  • Filter By Author

Page 1 of 4512345...102030...Last »

FDA clears Keytruda based on cancer genetics

Merck & Co.’s Keytruda became the first cancer drug FDA-approved based on a patients’ specific genetic traits regardless of where in the body the disease originated.

Read More »

FDA to review Opdivo for HCC indication

The U.S. FDA accepted a supplemental BLA that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma after prior sorafenib therapy.

Read More »

26 Patients Dead After Replacing Controller for Abbott’s HeartMate II Blood Pumps at Home

Abbott Laboratories is recalling for more than 28,000 of its HeartMate II blood pumps after 26 patients died after attempting to exchange controllers while away from the hospital.

Read More »

FDA Approves Kevzara for Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients

The U.S. FDA approved Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

Read More »

FDA approves first drug to specifically treat GCA

The U.S. FDA expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis.

Read More »

CHMP backs Novartis’ Zykadia for first-line use

Novartis’ push to win approval for Zykadia as an initial treatment for a type of lung cancer got a lift with a positive recommendation from the EMA’s CHMP.

Read More »

FDA Approves Keytruda for Bladder Cancer

Merck’s Keytruda (pembrolizumab) received FDA approval for two new indications for certain patients with locally advanced or metastatic urothelial carcinoma, including first-line treatment in patients ineligible for cisplatin-containing chemotherapy.

Read More »

FDA Approves Kalydeco for More Than 900 People Ages 2 and Older with Cystic Fibrosis Who Have Certain Residual Function Mutations

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration approved Kalydeco (ivacaftor) for use in people with cystic fibrosis ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Read More »

FDA clinical hold on Concert’s hair loss drug

Concert Pharmaceuticals Inc. said the U.S. FDA imposed a clinical hold on a trial testing the company’s drug to treat alopecia areata, a type of hair loss.

Read More »

FDA warns of foot, leg amputations with J&J diabetes drug

Johnson & Johnson is required to add new warnings to its diabetes drug Invokana about the risk of foot and leg amputations, the U.S. Food and Drug Administration said.

Read More »

New FDA Head Discusses First Order of Business

The new U.S. FDA Commissioner Scott Gottlieb hit the ground running with an all-staff meeting at the regulatory agency to lay out his priorities and goals.

Read More »

FDA approves Merck combo for lung cancer

U.S. health regulators approved Merck & Co.’s Keytruda in combination with chemotherapy for previously untreated advanced lung cancer.

Read More »

It’s Official: New FDA Head Confirmed

Scott Gottlieb is returning to the U.S. Food and Drug Administration as its new chief after the U.S. Senate confirmed his appointment by a vote of 57 to 42.

Read More »

Immuno-oncology drug approved for bladder cancer

U.S. health regulators granted accelerated approval for Pfizer Inc.’s immuno-oncology drug Bavencio to treat advanced bladder cancer, marking the second approval in less than two months for the treatment developed along with Germany’s Merck KGaA.

Read More »

FDA approves first ALS treatment in more than two decades

The FDA approved Mitsubishi Tanabe Pharma’s treatment for the fatal neurological disorder amyotrophic lateral sclerosis (ALS), the first such U.S. regulatory approval in more than two decades.

Read More »

Keytruda EU Approval for Hematologic Malignancy

The European Commission approved Merck’s anti-PD-1 therapy Keytruda for treating adult patients with relapsed or refractory classical Hodgkin lymphoma.

Read More »

AstraZeneca immunotherapy wins FDA approval

U.S. regulators approved AstraZeneca’s key immunotherapy drug Imfinzi (durvalumab) as a treatment for bladder cancer, marking the first commercial green light for a product the company hopes will go on to sell billions of dollars.

Read More »

FDA approves Novartis’ leukemia treatment

The U.S. FDA approved Novartis AG’s Rydapt as an initial treatment for acute myeloid leukemia (AML) as well as certain other blood disorders.

Read More »

FDA Approves BioMarin’s drug for Batten Disease

BioMarin Pharmaceutical announced that the U.S. FDA approved Brineura (cerliponase alfa) for the rare disease, late infantile neuronal ceroid lipofuscinosis type 2 (CLN2).

Read More »

FDA approves Bayer’s Stivarga to treat most common liver cancer

The U.S. Food and Drug Administration said it approved Bayer AG’s drug Stivarga to treat liver cancer, the first such approval in nearly a decade.

Read More »

Page 1 of 4512345...102030...Last »

Ad Right Top


Extensive pharmaceutical business and marketing intelligence. For back issues, please contact

April 2017 Focus: Agency Profiles, Manny Awards and more!


Ad Right Bottom

Password Reset
Please enter your e-mail address. You will receive a new password via e-mail.

Main Navigation