Regulatory
Track how regulatory decisions alter competitive positioning, launch timelines, and investor expectations across therapeutic areas.
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REGULATORY
The FDA has accepted the New Drug Application (NDA) for Vepdegestrant (NDA219835) submitted by Arvinas Operations.
REGULATORY
The FDA has approved the application ANDA207694 for Glycerol Phenylbutyrate submitted by Lupin.
REGULATORY
The FDA has approved the ANDA219593 application for Pregabalin submitted by Unichem.
STRATEGY
The FDA has approved the combination of Sitagliptin and Metformin Hydrochloride under application ANDA202426 by Apotex.
REGULATORY
The FDA has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) for use in combination with androgen receptor pathway inhibitors in adults with PSMA-positive metastatic prostate cancer.
REGULATORY
Resmed has issued a correction for certain Astral ventilators due to a failure of an electrical component that may lead to therapy interruption or failure.
REGULATORY
The FDA has approved a supplemental application for VEKLURY (remdesivir) submitted by Gilead Sciences.
REGULATORY
The FDA has approved QLONILIK, containing Clonidine Hydrochloride, under NDA221094.
STRATEGY
The FDA has granted approval for Sugammadex Sodium under application ANDA218814 submitted by SteriScience.
REGULATORY
Teva Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Sugammadex Sodium.
STRATEGY
The FDA has granted approval for the ANDA219448 application for Sugammadex Sodium submitted by Fresenius Kabi.
COMPETITIVE
Reddy's has received FDA approval for Sugammadex Sodium under ANDA214236.
STRATEGY
Sandoz has received an Abbreviated New Drug Application (ANDA) approval for Sugammadex Sodium.
REGULATORY
The FDA has approved Sugammadex Sodium under application ANDA214364 submitted by Gland Pharma.
CLINICAL
Mosunetuzumab is approved for follicular lymphoma and has NCCN recommendations for other B-NHL subtypes.
REGULATORY
The FDA has granted approval for Sugammadex Sodium under ANDA214368, submitted by MSN.
REGULATORY
Datroway has been approved in the EU as the only TROP2-directed therapy demonstrating overall survival benefit for first-line treatment in metastatic TNBC patients not eligible for immunotherapy.
STRATEGY
Cipla's application ANDA210435 for Lenalidomide has received an abbreviated approval status from the FDA.
REGULATORY
The FDA has granted priority review status for the supplemental NDA for NUPLAZID, an indication for pimavanserin tartrate.
REGULATORY
The FDA has granted accelerated approval for afamitresgene autoleucel, TCR therapy targeting MAGE-A4 in synovial sarcoma.
REGULATORY
The European Commission has granted marketing authorization for the Pfizer-BioNTech XFG-adapted COVID-19 vaccine for individuals 6 months and older.
STRATEGY
The FDA has approved the ANDA217554 submission for Lenalidomide by Deva Holding AS.
REGULATORY
The FDA has granted priority review status for the supplemental application of NUPLAZID (pimavanserin tartrate) submitted by ACADIA Pharmaceuticals.
STRATEGY
The FDA has accepted the ANDA submission for Lenalidomide from Torrent Pharmaceuticals.
REGULATORY
The FDA has granted approval for a supplemental application for Pomalidomide submitted by Mylan.
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