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Aug 07, 2026
BioMarin reported Q2 2026 revenues of $990 million, up 20% Y/Y, and raised guidance. It filed an sNDA for VOXZOGO in hypochondroplasia and advanced BMN 333, BMN 820, and BMN 351.
Jul 27, 2026
Rising Pharma Holdings Inc. recalls four lots of 5 mg cetirizine hydrochloride allergy tablets after a pharmacy tech noticed possible cross-contamination with ranitidine, posing life-threatening risks to hypersensitive individuals.
Jul 13, 2026
Aquestive Therapeutics disclosed FDA deficiencies in its Anaphylm NDA, halting labeling discussions and causing a 37% stock drop. The setback does not represent a final rejection, leaving a path for resubmission.
Jun 16, 2026
Grifols has launched FESILTY (fibrinogen, human-chmt) in the U.S., a fibrinogen concentrate FDA-approved in December 2025 for acute bleeding episodes in patients with congenital fibrinogen deficiency. The highly purified product, developed by Biotest, enables rapid fibrinogen restoration and can be reconstituted in approximately three minutes.
Mar 20, 2026
Aquestive Therapeutics received a Complete Response Letter from the FDA for Anaphylm (dibutepinephrine) sublingual film, citing deficiencies in human factors validation and packaging. The company plans to resubmit as early as Q3 2026.
Feb 16, 2026
CSL Seqirus announced that neffy adrenaline nasal spray has been approved in Australia for emergency treatment of anaphylaxis in adults and children 15kg+ and aged four years and over, marking the first new adrenaline administration method approved in over 30 years.
Jan 16, 2026
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.
