pharmaphorum

JULY 19, 2022

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months. The company is gunning for sales in atopic dermatitis alone of $1.5 million people in the US.

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Sales FDA Approval Regulation Drugs 98

pharmaphorum

FEBRUARY 28, 2022

Amryt Pharma has been handed a major blow by the FDA, after the US regulator rejected its marketing application for Oleogel-S10, its drug for rare and debilitating skin disease epidermolysis bullosa (EB).

Drugs 98

Drugs Marketing Regulation FDA Approval 98

pharmaphorum

MAY 25, 2022

Roivant group company Dermavant has made the transition to a commercial-stage company after getting FDA approval for Vtama, a drug for psoriasis that it claims could be a game-changer in the treatment of the skin disorder. Otezla – which Amgen acquired for $13.4

Drugs 52

Drugs FDA Approval Licensing Licensing 52

pharmaphorum

SEPTEMBER 22, 2021

Analysts said that the warning, which follows an FDA review of the safety of the JAK inhibitor class, could put a brake on sales of the new drug. The FDA’s action date on the drug was originally in April but has been pushed back twice.

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Sales Regulation FDA Approval Marketing 52

pharmaphorum

OCTOBER 28, 2020

Pfizer could be just a few months away from getting FDA approval for its JAK1 inhibitor abrocitinib in atopic dermatitis, a drug that CEO Albert Bourla believes hasn’t been given the credit it is due by Wall Street analysts.

Drugs 52

Drugs Sales Marketing FDA Approval 52

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). Product Sales Performance. Key results include: Total revenues increased 5% to $6.5

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. billion in pharmaceutical sales from 2021. billion in 2022, a 23.43

Sales 98

Sales Manufacturing FDA Approval Life Science 98