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Approvals

FMBA Files for Registration of “Allergarda,” a Recombinant Vaccine for Birch Pollen Allergy

Approvals Techno -
The vaccine is currently in Phase III clinical trials, evaluating its efficacy against a placebo in patients with allergic rhinitis.

Rune Labs gets FDA approval to use Apple Watch to track Parkinson’s disease symptoms

Approvals Techno -
San Francisco-based startup Rune Labs on Monday said it received clearance from the U.S. Food and Drug Administration to use the Apple Watch to...
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FDA approves Lilly and Incyte’s Olumiant® for alopecia areata

Global Markets Techno -
Eli Lilly and Company and Incyte announced  that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib),...

Novavax’s COVID-19 vaccine received FDA AdCom approval, clearing “serious hurdles”

Global Markets Techno -
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, Tuesday announced the...

FDA approves Sanofi’s Dupixent for widespread use in the United States

Regulatory Techno -
Sanofi won expanded U.S. approval for its best-selling Dupixent injection to treat an allergic inflammation of the esophagus, the...

MicroGEM’s PCR test, which gives results in 27 minutes, received EUA approval from FDA

Regulatory Techno -
MicroGEM has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the MicroGEM...

Sun Pharma shares up 4% after FDA approves mesalamine capsules

Approvals Techno -
Sun Pharmaceutical Industries Limited, announced that it has received final approval from US FDA for its Abbreviated New Drug...

Lupin receives two FDA approvals and share price jumps

Regulatory Techno -
Global pharma major Lupin Ltd, May 06th, announced that it has received approval from the United States Food and...
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PHARMPROM is a premier digital resource for the pharmaceutical sector, combining breaking news, deep insights, and key market events. We cover the entire product lifecycle—from R&D and manufacturing to distribution—in strict accordance with Good Pharmaceutical Practices (GxP).

Disclaimer All content on pharmprom.net is for informational purposes only and does not constitute medical advice. The materials are intended exclusively for industry professionals and are not addressed to the general public.

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Headlines

FMBA Files for Registration of “Allergarda,” a Recombinant Vaccine for Birch Pollen Allergy

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The vaccine is currently in Phase III clinical trials, evaluating its efficacy against a placebo in patients with allergic rhinitis.

Russia Updates Pharma Licensing: New Timelines and Remote Inspections

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The Russian Government has approved a new resolution updating...

GMP-Inspections of veterinary manufacturers in July – October 2025

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The review provides available information on the inspection of...

Nanolek Launches Russia’s First Full-Cycle Production of Human Papillomavirus (HPV) Vaccine

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The biopharmaceutical company Nanolek, with the support of the...

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