HealthQuill USFDA
Merck’s Biological Licence Application for a pulmonary arterial hypertension drug has been accepted for a priority review by the FDA.
Drugs Health Pharma

Merck gets priority review nod from USFDA for hypertension drug 

HQ Team September 28, 2023: Merck’s Biological Licence Application for a pulmonary arterial hypertension drug has been accepted for a priority review by.

Read More
Eisai Co., and Biogen Inc., announced that their drug to treat Alzheimer’s disease and cognitive impairment has been approved in Japan.
Drugs Health Pharma

Japan approves Eisai Co, Biogen Inc’s Leqembi for Alzheimer’s 

HQ Team September 25, 2023: Eisai Co., and Biogen Inc., announced that their drug to treat Alzheimer’s disease and cognitive impairment has been.

Read More
The European Commission granted Pfizer Inc., a marketing authorisation for its once-daily oral capsule to treat hair loss or alopecia aerate.
Drugs Health Pharma

Pfizer’s oral capsule Litfulo to treat hair loss gets EU approval

HQ Team September 19, 2023: The European Commission granted Pfizer Inc., a marketing authorisation for its once-daily oral capsule to treat hair loss.

Read More
The USFDA stated that Accord Healthcare Inc.’s generic tacrolimus oral capsules, meant to treat organ rejection, were no longer automatically substitutable at the pharmacy due to increased toxicity.
Drugs Health Pharma

FDA rules Accord’s tacrolimus oral drug not “substitutable” for US market

HQ Team September 19, 2023: The USFDA stated that Accord Healthcare Inc.’s generic tacrolimus oral capsules, meant to treat organ rejection, were no.

Read More
The USFDA has approved GSK Plc’s oral therapy to treat anaemia in patients with myelofibrosis, a type of bone cancer.
Drugs Health Pharma

USFDA gives nod for GSK’s Ojjaara bone cancer therapy 

The USFDA has approved GSK Plc’s oral therapy to treat anaemia in patients with myelofibrosis, a type of bone cancer.

Read More
The US national public agency has recommended a COVID-19 vaccination policy where updated shots are given starting from six-month-old infants — in variance with the policies of European counterparts.
Drugs Health Pharma

CDC, ECDC differ on vaccination program for fall-winter season

HQ Team September 13, 2023: The US national public agency has recommended a COVID-19 vaccination policy where updated shots are given starting from.

Read More
The USFDA, in a bid to protect consumers, has issued warning letters to eight companies for marketing illegal and harmful ophthalmic products.
Health Medical Pharma

FDA warns 8 firms for marketing harmful eye products 

HQ Team September 12, 2023: The USFDA, in a bid to protect consumers, has issued warning letters to eight companies for marketing illegal.

Read More
The US drug and medicine regulator, FDA, has approved COVID-19 vaccines made by Moderna Inc., Pfizer Inc., and BioNTech Manufacturing Gmb., to target new variants of the virus.
Drugs Health Pharma

USFDA green lights vaccines to fight COVID-19 variants in flu season

HQ Team September 12, 2023: The US drug and medicine regulator, the FDA, approved COVID-19 vaccines made by Moderna Inc., Pfizer Inc., and  BioNTech.

Read More
Britain’s Medicines and Healthcare products Regulatory Agency has cleared a vaccine made by Pfizer Inc., and its German partner BioNTech SE that targets Omicron XBB.1.5 subvariant alone.
Drugs Health Pharma

Pfizer, BioNTech’s Covid-19 variant vaccine gets UK nod

HQ Team September 6, 2023: Britain’s Medicines and Healthcare products Regulatory Agency has cleared a vaccine made by Pfizer Inc., and its German.

Read More
Takeda Pharmaceutical’s subsidiary, Shire Plc., was granted an FDA nod for making generic chewable tablets to treat attention-deficit, hyperactivity disorder, and moderate to severe binge disorder in adults.
Drugs Health Pharma

First generic versions of Japan’s Takeda ADHD tabs gets FDA nod

HQ Team August 29, 2023: The US Food and Drug Administration has approved several first generics of Takeda Pharmaceutical subsidiary, Shire Plc’s Vyvanse.

Read More