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FDA approves paediatric LEMS drug pharmaceutical-technology
May 09, 2019
The US Food and Drug Administration (FDA) has approved Jacobus Pharmaceutical’s Ruzurgi (amifampridine) as a treatment for Lambert-Eaton myasthenic syndrome (LEMS).
Exelixis Announces U.S. FDA Approval of CABOMETYX (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma firstwordpharma
January 15, 2019
ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc.(NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated wi
Merck & Co begins US filing of Ebola vaccine pharmaphorum
December 11, 2018
Merck & Co has begun a rolling filing in the US of its Ebola Zaire vaccine, known as V920, after the FDA said it could represent a breakthrough in treatment.
Alembic Pharma gets US FDA nod for Xylocaine pain relief ointment expressbpd
November 26, 2018
Alembic Pharmaceuticals stated that its joint venture with Aleor Dermaceuticals has received approval from the US health regulator for Xylocaine ointment, used for temporary relief of pain associated with minor burns, including sunburn, abrasions of the s
Allergan works toward blockbuster goal with new CoolSculpting OK fiercepharma
October 11, 2018
Part of Allergan’s medical aesthetics strategy depends on securing follow-on indications for its CoolSculpting fat-freezing system, and the product recently came through with a new approval.
U.S.-China trade war; Takeda’s Alunbrig beats Xalkori; FDA scolds Huahai fiercepharma
September 29, 2018
After the latest round of tariff war escalation, nearly all U.S. medtech exports to China are now subject to additional tariffs. Takeda's Alunbrig triumphed over Pfizer's Xalkori in a head-to-head first-line ALK-positive lung ...
ARMGO Pharma Receives FDA Orphan Drug Designation for ARM210 https://www.americanpharmaceuticalreview.com/1315-
September 07, 2018
ARMGO Pharma announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ARM210 (also known as S48168), a potential treatment for patients with Ryanodine Receptor Type 1 Related ...
FDA hits Mexican drugmaker Degasa with warning letter fiercepharma
May 02, 2018
The FDA issued a warning letter to Mexican finished-pharmaceutical manufacturer Degasa for issues including misbranding...
Two FDA drug review Directors to leave the agency, with no permanent replacements in place pharmafile
April 28, 2018
The FDA has revealed that two of its prominent Directors are set to retire from the agency, leaving three of its 19 drug review divisions without permanent figures to lead them...
DRL gets EIR from US FDA expressbpd
April 11, 2018
Dr Reddy’s Laboratories (DRL) has received establishment inspection report from the US health regulator for its Cuernavaca facility in Mexico.

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