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3171 News Found

Zydus receives final approval from USFDA for Tretinoin Cream
Drug Approval | April 28, 2024

Zydus receives final approval from USFDA for Tretinoin Cream

The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)


Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal
Drug Approval | April 28, 2024

Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal

The USFDA has issued 5 observations pursuant to the completion of audit


Parexel and Palantir to accelerate clinical data delivery and power clinical outcomes for patients
Digitisation | April 28, 2024

Parexel and Palantir to accelerate clinical data delivery and power clinical outcomes for patients

Parexel will leverage Palantir’s Foundry and Artificial Intelligence Platform to further power its clinical data platform


CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine
Drug Approval | April 27, 2024

CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine

If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU


FDA approves Biktarvy label update with data for pregnant adults with HIV
Drug Approval | April 27, 2024

FDA approves Biktarvy label update with data for pregnant adults with HIV

Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV


Merck 1Q 2024 sales up 9% to US$ 15.8 billion
News | April 26, 2024

Merck 1Q 2024 sales up 9% to US$ 15.8 billion

Sales reflect continued strong growth in oncology and vaccines


Voydeya approved in the EU as add-on treatment to ravulizumab
News | April 23, 2024

Voydeya approved in the EU as add-on treatment to ravulizumab

ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue


Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines
Drug Approval | April 23, 2024

Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines

Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies


Lupin launches Mirabegron Extended-Release Tablets in US
Drug Approval | April 22, 2024

Lupin launches Mirabegron Extended-Release Tablets in US

Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US


Biocon receives approval from SAHPRA for Tacrolimus Capsule
News | April 22, 2024

Biocon receives approval from SAHPRA for Tacrolimus Capsule

Tacrolimus is an immunosuppressant used in the treatment of organ transplant patients